BD CONVENTIONAL NEEDLES
Report
- Report Number
- 3002682307-2024-00261
- Event Type
- Malfunction
- Date Received
- January 2, 2025
- Date of Event
- December 13, 2024
- Report Date
- April 1, 2025
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- FMI
- UDI-DI
- 00382903031290
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # (B)(4)) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: CONVENTIONAL NEEDLES. DEVICE FAILURE: PACKAGE DIFFICULT TO OPEN.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 303129 AND LOT NUMBER 241008. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, BOTH PICTURE AND PHYSICAL SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. SEVEN (7) BLISTER PACKAGES WITH BROKEN PACKAGING PAPER WERE RECEIVED. TWENTY (20) RETAINED SAMPLES WERE OBTAINED FOR ADDITIONAL REVIEW. THE RETAINED SAMPLE BLISTERS WERE SEPARATED WITHOUT ANY ISSUES. THE RETAINED PACKAGES WERE THEN OPENED WITHOUT ANY ISSUES. BASED ON THE PROVIDED FEEDBACK AND THE RETURNED SAMPLE INVESTIGATION RESULTS, WE UNDERSTAND THAT AN ISSUE WITH THE CUTTING OF THE UNIT PACKAGES COULD HAVE TAKEN PLACE. THE PACKAGING MACHINE HAS A CUTTING SYSTEM WHERE THE DIFFERENT STRIPS ARE CUT. THIS ISSUE COULD RESULT IF A FAILURE IN THE CUTTING SYSTEM OCCURS AND PRODUCES UNCUT BLISTERS, WHICH RESULTS IN DIFFICULTIES OPENING THE BLISTERS. BASED ON THE PREVENTIVE MEASURES IN PLACE AND OUR RETAINED SAMPLE INVESTIGATION, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.
IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES PACKAGE POORLY PERFORATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING OFTEN TEARS, RESULTING IN A LOT OF MATERIAL BEING WASTED. BD BLUNT FILL NEEDLE 18G ARE AVAILABLE IN A MULTIPACK. THEY HAVE TO BE SEPARATED FROM EACH OTHER FOR USE. THE PACKAGING OFTEN TEARS AS A RESULT, RESULTING IN A LOT OF MATERIAL BEING WASTED. DEFECTS ALSO OCCUR IN THE OUTER PAPER POCKET AND THE DEVICE IS NO LONGER STERILE. WHEN DID THE INCIDENT OCCUR? BEFORE USE.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 638884 | BD CONVENTIONAL NEEDLES | NEEDLES, HYPODERMIC | FMI | BECTON DICKINSON, S.A. | 241008 | 00382903031290 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |