PEN NDL 32G 4MM
Report
- Report Number
- 2243072-2020-00535
- Event Type
- Malfunction
- Date Received
- March 31, 2020
- Date of Event
- April 1, 2020
- Report Date
- May 26, 2020
- Manufacturer
- BECTON DICKINSON AND CO.
- Product Code
- FMI
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
PER ADDITIONAL INFORMATION RECEIVED, THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.3. DATE OF EVENT: (B)(6) 2020. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDLS 32G 4MM WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122, BATCH NO. 9162522. MY WIFE USES BD PEN NEEDLES 4MM FOR THE PAST COUPLE OF YEARS. HER LAST BOX FROM CDISTRIBUTOR HAD SEVERAL NEEDLES NOT LETTING HER TRULICITY INSULIN THROUGH FOR INJECTION. LOOKS LIKE A BAD LOT. D.1. MEDICAL DEVICE BRAND NAME: PEN NDLS 32G 4MM. D.1. COMMON DEVICE NAME: PEN NEEDLE. D.2. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON AND CO. D.2. MEDICAL DEVICE TYPE: FMI. D.4. MEDICAL DEVICE CATALOG #: 320122. D.4. MEDICAL DEVICE LOT #: 9162522. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). E.1. INITIAL REPORTER ADDR 1: (B)(6) . E.1. INITIAL REPORTER CITY: (B)(6) . E.1. INITIAL REPORTER ZIP: (B)(6) . G.1. MANUFACTURING LOCATION: BECTON DICKINSON AND CO. G.4. DATE RECEIVED BY MANUFACTURER: 2020-04-20. G.5. PMA/510(K)#: N/A. H.4. DEVICE MANUFACTURE DATE: 2019-06-11.
H.6. INVESTIGATION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED AS OF 28 APRIL 2020 THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 5/13/2020 H.6. INVESTIGATION: CUSTOMER RETURNED (11) OPEN 4MM, 32G PEN NEEDLES FROM LOT # 9162522. CUSTOMER STATES THAT THE NEEDLES ARE NOT LETTING INSULIN THROUGH DURING INJECTION AND PRIMING. ALL RETURNED PEN NEEDLES WERE EXAMINED AND 4 SAMPLES EXHIBITED A BENT NON PATIENT END OF THE CANNULA AND 4 SAMPLES EXHIBITED A BROKEN NON PATIENT END OF THE CANNULA. ALL REMAINING SAMPLES WERE TESTED AND ALL WERE ABLE TO EXPEL PROPERLY WITHOUT ANY OBSERVED DEFECTS. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. 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 H.10.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDLS 32G 4MM WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122, BATCH NO. 9162522. MY WIFE USES BD PEN NEEDLES 4MM FOR THE PAST COUPLE OF YEARS. HER LAST BOX FROM CDISTRIBUTOR HAD SEVERAL NEEDLES NOT LETTING HER TRULICITY INSULIN THROUGH FOR INJECTION. LOOKS LIKE A BAD LOT.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDLS 32G 4MM WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 9162522. MY WIFE USES BD PEN NEEDLES 4MM FOR THE PAST COUPLE OF YEARS. HER LAST BOX FROM CDISTRIBUTOR HAD SEVERAL NEEDLES NOT LETTING HER TRULICITY INSULIN THROUGH FOR INJECTION. LOOKS LIKE A BAD LOT.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDLS 32G 4MM WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 320122 BATCH NO. 9162522. MY WIFE USES BD PEN NEEDLES 4MM FOR THE PAST COUPLE OF YEARS. HER LAST BOX FROM DISTRIBUTOR HAD SEVERAL NEEDLES NOT LETTING HER TRULICITY INSULIN THROUGH FOR INJECTION. LOOKS LIKE A BAD LOT.
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: 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. 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.
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF AN UNSPECIFIED BD PEN NEEDLE WERE UNABLE TO DELIVER INSULIN/MEDICATION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. MY WIFE USES BD PEN NEEDLES 4MM FOR THE PAST COUPLE OF YEARS. HER LAST BOX FROM DISTRIBUTOR HAD SEVERAL NEEDLES NOT LETTING HER TRULICITY INSULIN THROUGH FOR INJECTION. LOOKS LIKE A BAD LOT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 365536 | PEN NDL 32G 4MM | PEN NEEDLE | FMI | BECTON DICKINSON AND CO. | 9162522 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |