BD ULTRA FINE¿ PEN NEEDLES
Report
- Report Number
- 2243072-2019-00507
- Event Type
- Malfunction
- Date Received
- March 18, 2019
- Date of Event
- February 27, 2019
- Report Date
- August 5, 2019
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- PMA / PMN Number
- K162516
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES STOP WORKING AND NEED TO RE-INJECT TO GET FULL DOSAGE. THIS COMPLAINT HAS BEEN SPLIT TO RECORD OCCURRENCES. THIS PR WAS CREATED TO RECORD OCCURRENCES FROM LAST MONTH. SEE RELATED (B)(4) FOR OCCURRENCE FROM TWO MONTHS AGO. VERBATIM: I HAVE HAD BAD EXPERIENCES WITH YOUR PEN NEEDLES RECENTLY. TWO MONTHS AGO, AT LEAST TWENTY OF THE NEEDLES DIDN'T WORK. THE NEXT MONTH, I HAD MUCH BETTER RESULTS. THE LAST BOX THAT I JUST STARTED USING SEEMS LIKE IT IS GOING TO HAVE A HIGH QUANTITY OF BAD NEEDLES. THREE NEEDLES IN A ROW DIDN'T WORK. THEY START OUT FINE BUT WON'T DISPENSE THE ENTIRE DOSE. THIS MEANS I HAVE TO CHANGE THE NEEDLE AND RE-STICK MYSELF. I'VE NEVER HAD THIS PROBLEM BEFORE AT THIS HIGH QUANTITY. ONCE I A WHILE A PEN NOT WORKING I UNDERSTAND. BUT THIS IS BECOMING THE NORM. I HAVEN'T CHANGED THE WAY I USE IT OR CHANGED MY MEDICATION. D.1. MEDICAL DEVICE BRAND NAME: BD ULTRA FINE¿ PEN NEEDLES, D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO., D.4. MEDICAL DEVICE CATALOG: 320122, D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8348566, D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023, H.4. DEVICE MANUFACTURE DATE: 2/13/2019; D.4. MEDICAL DEVICE LOT #: 8270626, D.4. MEDICAL DEVICE EXPIRATION DATE: 10/31/2023, H.4. DEVICE MANUFACTURE DATE: 11/13/2018; D.4. MEDICAL DEVICE LOT #: 8275940, D.4. MEDICAL DEVICE EXPIRATION DATE: 9/30/2023, H.4. DEVICE MANUFACTURE DATE: 10/2/2018; D.4. MEDICAL DEVICE LOT #: 8275939, D.4. MEDICAL DEVICE EXPIRATION DATE: 9/30/2023, H.4. DEVICE MANUFACTURE DATE: 10/2/2018; D.4. MEDICAL DEVICE LOT #: 9009592, D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2024, H.4. DEVICE MANUFACTURE DATE: 3/11/2019. G.1. MANUFACTURING LOCATION: BECTON DICKINSON AND CO. G.5. PMA / 510(K)#: K162516. H.6. INVESTIGATION SUMMARY: CUSTOMER RETURNED (30) USED 32G X 4MM BD PEN NEEDLES: 9 FROM LOT 8348566, 5 FROM LOT 8270626, 5 FROM LOT 8275939, 6 FROM LOT 8275940, 2 FROM LOT 9009592, AND 3 WITHOUT TEAR DROP LABELS ATTACHED (LOT UNKNOWN). CONSUMER REPORTED THEY START OUT FINE BUT WON'T DISPENSE THE ENTIRE DOSE. ALL 9 SAMPLES FROM LOT 8348566 WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 5 WITH BROKEN NON-PATIENT END (NPE) CANNULAS; 1 OF THESE SAMPLES ALSO HAD A BENT PATIENT END (PE) CANNULA. 4 WITH BENT NPE CANNULAS. ALL 5 SAMPLES FROM LOT 8270626 WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 4 WITH BROKEN NPE CANNULAS. 1 WITH A BENT NPE CANNULA. ALL 5 SAMPLES FROM LOT 8275939 WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 4 WITH BROKEN NPE CANNULAS; 1 OF THESE SAMPLES ALSO HAD A BENT PE CANNULA. 1 WITH A BENT NPE CANNULA. ALL 6 SAMPLES FROM LOT 8275940 WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 4 WITH BROKEN NPE CANNULAS. 2 WITH BENT NPE CANNULAS. BOTH (2) SAMPLES FROM LOT 9009592 WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 1 WITH A BROKEN NPE CANNULA. 1 WITH A BENT NPE CANNULA. ALL 3 SAMPLES WITHOUT TEAR DROP LABELS ATTACHED (LOT UNKNOWN) WERE EXAMINED AND THE FOLLOWING WAS OBSERVED: 1 WITH A BROKEN NPE CANNULA. 1 WITH A BENT NPE CANNULA. 1 WITH A GOOD NPE CANNULA; THIS SAMPLE WAS TESTED FOR FLOW USING A TEST PEN INJECTOR AND PASSED. AS ALL 30 SAMPLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE LIKELY CAUSE OF THE BENT OR BROKEN NPE CANNULAS OR BENT PE CANNULAS IS HUMAN ERROR DURING USE OF THE PEN NEEDLE; THE BENT OR BROKEN NPE CANNULAS WERE LIKELY THE RESULT OF USER ERROR DURING PEN NEEDLE ATTACHMENT TO A PEN INJECTOR. THE BENT OR BROKEN NPE CANNULAS OR BENT PE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE THE CUSTOMER WOULD THINK THAT THE PEN NEEDLES WERE CLOGGED, AS REPORTED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THESE PACKAGED LOTS CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. BASED ON THE SAMPLES AND/OR PHOTO(S) RECEIVED THE INVESTIGATION CONCLUDED: -CONFIRMED: BD WAS ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURES (BENT OR BROKEN NPE CANNULAS, AND BENT PE CANNULAS). COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME. THE POSSIBLE ROOT CAUSE FOR THESE ISSUES IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. H3 OTHER TEXT: SEE SECTION H.10.
H.6. INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. IF SAMPLES ARE RECEIVED IN THE FUTURE THE COMPLAINT WILL BE REOPENED FOR FURTHER INVESTIGATION. UNABLE TO PERFORM DHR DUE TO UNKNOWN LOT NUMBER FOR CLOG. AS NO SAMPLES AND/OR PHOTO(S) WERE RECEIVED THE INVESTIGATION CONCLUDED: -UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. BASED ON THE ABOVE, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.
IT WAS REPORTED THAT BD ULTRA FINE¿ PEN NEEDLES STOP WORKING AND NEED TO RE-INJECT TO GET FULL DOSAGE. THIS COMPLAINT HAS BEEN SPLIT TO RECORD OCCURRENCES. THIS PR WAS CREATED TO RECORD OCCURRENCES FROM LAST MONTH. SEE RELATED (B)(4) FOR OCCURRENCE FROM TWO MONTHS AGO. VERBATIM: I HAVE HAD BAD EXPERIENCES WITH YOUR PEN NEEDLES RECENTLY. TWO MONTHS AGO, AT LEAST TWENTY OF THE NEEDLES DIDN'T WORK. THE NEXT MONTH, I HAD MUCH BETTER RESULTS. THE LAST BOX THAT I JUST STARTED USING SEEMS LIKE IT IS GOING TO HAVE A HIGH QUANTITY OF BAD NEEDLES. THREE NEEDLES IN A ROW DIDN'T WORK. THEY START OUT FINE BUT WON'T DISPENSE THE ENTIRE DOSE. THIS MEANS I HAVE TO CHANGE THE NEEDLE AND RE-STICK MYSELF. I'VE NEVER HAD THIS PROBLEM BEFORE AT THIS HIGH QUANTITY. ONCE I A WHILE A PEN NOT WORKING I UNDERSTAND. BUT THIS IS BECOMING THE NORM. I HAVEN'T CHANGED THE WAY I USE IT OR CHANGED MY MEDICATION.
IT WAS REPORTED THAT UNSPECIFIED BD PEN NEEDLES¿ STOP WORKING AND NEED TO RE-INJECT TO GET FULL DOSAGE. THIS COMPLAINT HAS BEEN SPLIT TO RECORD OCCURRENCES. THIS PR WAS CREATED TO RECORD OCCURRENCES FROM LAST MONTH. SEE RELATED (B)(4) FOR OCCURRENCE FROM TWO MONTHS AGO. VERBATIM: I HAVE HAD BAD EXPERIENCES WITH YOUR PEN NEEDLES RECENTLY. TWO MONTHS AGO, AT LEAST TWENTY OF THE NEEDLES DIDN'T WORK. THE NEXT MONTH, I HAD MUCH BETTER RESULTS. THE LAST BOX THAT I JUST STARTED USING SEEMS LIKE IT IS GOING TO HAVE A HIGH QUANTITY OF BAD NEEDLES. THREE NEEDLES IN A ROW DIDN'T WORK. THEY START OUT FINE BUT WON'T DISPENSE THE ENTIRE DOSE. THIS MEANS I HAVE TO CHANGE THE NEEDLE AND RESTICK MYSELF. I'VE NEVER HAD THIS PROBLEM BEFORE AT THIS HIGH QUANTITY. ONCE I A WHILE A PEN NOT WORKING I UNDERSTAND. BUT THIS IS BECOMING THE NORM. I HAVEN'T CHANGED THE WAY I USE IT OR CHANGED MY MEDICATION.
UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED THAT UNSPECIFIED BD PEN NEEDLES¿ STOP WORKING AND NEED TO RE-INJECT TO GET FULL DOSAGE. THIS COMPLAINT HAS BEEN SPLIT TO RECORD OCCURRENCES. THIS PR WAS CREATED TO RECORD OCCURRENCES FROM LAST MONTH. SEE RELATED (B)(4) FOR OCCURRENCE FROM TWO MONTHS AGO. VERBATIM: I HAVE HAD BAD EXPERIENCES WITH YOUR PEN NEEDLES RECENTLY. TWO MONTHS AGO, AT LEAST TWENTY OF THE NEEDLES DIDN'T WORK. THE NEXT MONTH, I HAD MUCH BETTER RESULTS. THE LAST BOX THAT I JUST STARTED USING SEEMS LIKE IT IS GOING TO HAVE A HIGH QUANTITY OF BAD NEEDLES. THREE NEEDLES IN A ROW DIDN'T WORK. THEY START OUT FINE BUT WON'T DISPENSE THE ENTIRE DOSE. THIS MEANS I HAVE TO CHANGE THE NEEDLE AND RE-STICK MYSELF. I'VE NEVER HAD THIS PROBLEM BEFORE AT THIS HIGH QUANTITY. ONCE I A WHILE A PEN NOT WORKING I UNDERSTAND. BUT THIS IS BECOMING THE NORM. I HAVEN'T CHANGED THE WAY I USE IT OR CHANGED MY MEDICATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 223941 | BD ULTRA FINE¿ PEN NEEDLES | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON AND CO. | SEE H.10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |