BD ULTRA FINE¿ PEN NEEDLES
Report
- Report Number
- 9616657-2019-00170
- Event Type
- Malfunction
- Date Received
- April 8, 2019
- Date of Event
- March 18, 2019
- Report Date
- May 1, 2019
- Manufacturer
- BECTON, DICKINSON AND CO.
- Product Code
- FMI
- UDI-DI
- 10885403928659
- PMA / PMN Number
- K162516
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: SITE LEGAL NAME (FDA): BECTON, DICKINSON AND CO. ¿ (B)(6) IRELAND MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON AND CO. ¿ (B)(4) IRELAND. MANUFACTURING LOCATION: BECTON, DICKINSON AND CO. ¿ (B)(4) IRELAND .
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. 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. 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 THE PEN DID NOT DEPRESS WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HER PEN WAS NOT ALLOWING HER TO PUSH DOWN. SHE THOUGHT IT WAS HER VICTOZA AND LEVAMIR, SHE FACED THE SAME PROBLEM WITH HER NEW PEN. INCIDENT- (B)(6) 2019. SAMPLE DISCARDED. SHE DOES NOT DO PRIMING SINCE HER INSULIN PEN ARE PREDETERMINED SUPPLY. SHE USES NEW PEN NEEDLE EACH TIME. SHE ALSO REPORTED HAD 80 PEN NEEDLES IN THE BOX AND THAT IS HOW THE PHARMACY SELLS HER TO MEET 3 MONTHS SUPPLY. LOT # 8205674; EXPIRATION DATE- 08-31-2023; ITEM # 320122 FOR BOTH ISSUES.
IT WAS REPORTED THAT THE PEN DID NOT DEPRESS WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HER PEN WAS NOT ALLOWING HER TO PUSH DOWN. SHE THOUGHT IT WAS HER VICTOZA AND LEVAMIR, SHE FACED THE SAME PROBLEM WITH HER NEW PEN. INCIDENT- (B)(6) 2019. SAMPLE DISCARDED. SHE DOES NOT DO PRIMING SINCE HER INSULIN PEN ARE PREDETERMINED SUPPLY. SHE USES NEW PEN NEEDLE EACH TIME. SHE ALSO REPORTED HAD 80 PEN NEEDLES IN THE BOX AND THAT IS HOW THE PHARMACY SELLS HER TO MEET 3 MONTHS SUPPLY. LOT # 8205674; EXPIRATION DATE- 08-31-2023; ITEM # 320122 FOR BOTH ISSUES.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT THE PEN DID NOT DEPRESS WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED HER PEN WAS NOT ALLOWING HER TO PUSH DOWN. SHE THOUGHT IT WAS HER VICTOZA AND LEVAMIR, SHE FACED THE SAME PROBLEM WITH HER NEW PEN. INCIDENT- ON (B)(6) 2019. SAMPLE DISCARDED. SHE DOES NOT DO PRIMING SINCE HER INSULIN PEN ARE PREDETERMINED SUPPLY. SHE USES NEW PEN NEEDLE EACH TIME. SHE ALSO REPORTED HAD 80 PEN NEEDLES IN THE BOX AND THAT IS HOW THE PHARMACY SELLS HER TO MEET 3 MONTHS SUPPLY. LOT # 8205674; EXPIRATION DATE- 08-31-2023; ITEM # 320122 FOR BOTH ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 283304 | BD ULTRA FINE¿ PEN NEEDLES | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON, DICKINSON AND CO. | 8205674 | 10885403928659 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |