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Adverse Event Report

3600-C.R. BARD ACCESS SYSTEMS PRODUCTS GROSHONG 4 FR PICC BASIC TRAY 150611071-LONG TERM INTRAVASCULAR CATHETER   back to search results
Model Number 6715405
Device Problems Leak(s); Implant, removal of
Event Date 04/26/2000
Event Type  Malfunction   Patient Outcome  Required Intervention;
Manufacturer Narrative

The product implicated is a 4-fr picc catheter. Returned is an assembled 4 fr two piece connector. A blood residue is found on the exterior of the connector. The catheter was not returned for evaluation. A chr review of the lot shows no other product complaints of similar nature. According to the notes contained in this file leakage occurred from the connector. This occurred after insertion. During initial decontamination, the connector was found patent to infusion. Upon further evaluation the strain relief oversleeve was removed from the distal connector. The inner diameter of the oversleeve measures 0. 061". The distal and proximal connectors were separated from each other and no segment of the catheter is found on the cannula of the proximal connector. Next, a razor blade was used to cut the distal connector in half. A cross sectional view of the distal connector shows the compression ring seated in its proper position. This complaint is inconclusive due to the complete sample was not returned for evaluation. No mfg defects were found with the distal and proximal connectors.

 
Event Description

Air leakage was found when slight pressure was applied after insertion.

 
Search Alerts/Recalls

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Brand NameGROSHONG 4 FR PICC BASIC TRAY
Type of Device150611071-LONG TERM INTRAVASCULAR CATHETER
Baseline Brand NameSPECIAL 4 FR PICC
Baseline Generic NameLONG TERM INTRAVASCULAR CATHETER
Baseline Catalogue Number6715405
Baseline Model Number6715405
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
3600-C.R. BARD ACCESS SYSTEMS PRODUCTS
5425 west amelia earhart dr.
salt lake city UT 84166
Manufacturer (Section D)
3600-C.R. BARD ACCESS SYSTEMS PRODUCTS
5425 west amelia earhart dr.
salt lake city UT 84166
Manufacturer (Section G)
BARD ACCESS SYSTEMS
5425 w amelia earhart drive
salt lake city UT 84116
Manufacturer Contact
stephanie erskine, dir
5425 w amelia earhart dr.
salt lake city , UT 84116
(801) 595 -0700
Device Event Key274023
MDR Report Key283173
Event Key265613
Report Number1720496-2000-00331
Device Sequence Number1
Product CodeDQO
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 05/11/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/19/2000
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/01/2004
Device MODEL Number6715405
Device Catalogue Number6715405
Device LOT Number36FJ0160
OTHER Device ID NumberBAS-0199
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/30/2000
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date04/26/2000
Device Ageno info
Event Location Unknown
Date Report TO Manufacturer05/11/2000
Date Manufacturer Received05/11/2000
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/01/1999
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on January 30, 2009

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