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Adverse Event Report

ALLEGIANCE HEALTHCARE BONE MARROW BIOPSY/ASPIRATION TRAY BONE MARROW BIOPSY TRAY   back to search results
Model Number EJT4511
Event Type  Malfunction   Patient Outcome  Other;
Event Description

Account reported that the needle has broken off of the handle four times in the last two weeks. The last complaint the handle came off the needle during a bone marrow biopsy procedure. The physician used a forceps to removed the needle from the pt's bone.

 
Manufacturer Narrative

No add'l pt info was available from the healthcare professional. There were two cannula and one cannula hub contained within the ej handle returned for examination. Your complaint has been confirmed. The returned units were not labeled as to which incident they belonged. A mfg record trace was initiated. There were no problems noted in either production or raw material records for the lot listed above. The units are statistically sampled for both separation force and torque requirements. The units are not release for use unless the requirements have been met as listed. This problem has been previously reported but had been very intermittent. Based on the most recent reports concerning the above listed lot this lot number has been placed on hold at the distribution level. In addition the ej needle will be redesigned to make the unit more robust.

 
Search Alerts/Recalls

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Brand NameBONE MARROW BIOPSY/ASPIRATION TRAY
Type of DeviceBONE MARROW BIOPSY TRAY
Baseline Brand NameBONE MARROW BIOPSY/ASPIRATION TRAY
Baseline Generic NameBONE MARROW BIOPSY TRAY
Baseline Catalogue NumberEJT4511
Baseline Model NumberEJT4511
Baseline Device FamilyBONE MARROW BIOPSY TRAY
Baseline Device 510(K) NumberK813338
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed11/01/1993
Manufacturer (Section F)
ALLEGIANCE HEALTHCARE
1500 waukegan rd.
mcgaw park IL 60085
Manufacturer (Section D)
ALLEGIANCE HEALTHCARE
1500 waukegan rd.
mcgaw park IL 60085
Manufacturer (Section G)
CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES
1430 waukegan rd.
mcgaw park IL 60085
Manufacturer Contact
michele donatich
1500 waukegan rd
mcgaw park , IL 60085
(847) 785 -3309
Device Event Key120196
MDR Report Key122725
Event Key115398
Report Number1423537-1997-00190
Device Sequence Number1
Product CodeKNW
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Other
Type of Report Initial
Report Date 09/26/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL NumberEJT4511
Device Catalogue NumberEJT4511
Device LOT NumberL7E023R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/22/1997
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received09/05/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial

Database last updated on February 28, 2009

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