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Adverse Event Report

BARD REYNOSA S.A. DE C.V. GROSHONG PICC LONG TERM INTRAVASCULAR CATHETER   back to search results
Model Number 7725507
Device Problem Implant, removal of
Event Date 05/25/2002
Event Type  Injury   Patient Outcome  Required Intervention;
Event Description

In 2002, pt's temperature rose to 103 degrees, during that day the pt was treated with tylenol & antibiotics. Tests did not indicate where the infection was, so it was decided to pull the picc as a precaution even though the exit site showed no inflammation or tenderness. The picc was sent to the lab & staph bacteria was found on the line.

 
Manufacturer Narrative

Findings: no product was returned for eval. It is impossible to determine a definitive cause for the complaint incident without a thorough eval of the picc. Therefore, the complaint of infection is inconclusive. Infections generally stem from maintenance, access or placement technique or the pt's physiology. Infections stemming from a non-sterile device would manifest shortly after placement rather than 2 months after placement. All bas products must meet stringent sterility and pyrogenicity testing requirements before they are released to distribution. The mfr maintains a validated sterilization cycle that ensures this product was sterile and non-pyrogenic upon customer receipt, so long as the integrity of the mfr's sterile seal has not been compromised.

 
Search Alerts/Recalls

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Brand NameGROSHONG PICC
Type of DeviceLONG TERM INTRAVASCULAR CATHETER
Baseline Brand NameGROSHONG 5FR D/L PICC
Baseline Generic NameIMPLANTED LONG TERM INTRAVASCULAR CATHETER
Baseline Catalogue Number7725507
Baseline Model Number7725507
Baseline Device 510(K) Number
Baseline Device PMA Number
Manufacturer (Section F)
BARD REYNOSA S.A. DE C.V.
boulevard montebello #1
parque industrial colonial
reynosa, tamaulipas
MEXICO
Manufacturer (Section D)
BARD REYNOSA S.A. DE C.V.
boulevard montebello #1
parque industrial colonial
reynosa, tamaulipas
MEXICO
Manufacturer Contact
nitin patill, mgr
5425 west amelia earhart dr
salt lake city , UT 84116
(801) 595 -0700
Device Event Key396481
MDR Report Key407499
Event Key385201
Report Number1720496-2002-00153
Device Sequence Number1
Product CodeDQO
Report Source Manufacturer
Source Type Other
Reporter Occupation Patient
Type of Report Initial
Report Date 06/25/2002
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/22/2002
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device MODEL Number7725507
Device LOT Number22DLA855
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date05/25/2002
Device Age2 mo
Event Location Hospital
Date Report TO Manufacturer06/25/2002
Date Manufacturer Received06/25/2002
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/01/2001
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Unkown

Database last updated on February 28, 2009

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