MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-02-01 for BD PEN NDL 32G 4MM 320555 manufactured by Becton Dickinson And Co..
[179105372]
Investigation summary: complaint evaluation / complaint history check for the event(s) that occurred. No samples (including photos) were returned therefore the complaint could not be confirmed occurrence: a complaint history check was performed and this is the 1st related complaint for needle stick & needle through shield on lot # 8352806. 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 investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer? S indicated failure as no samples or photos were returned 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. Root cause description: root cause cannot be determined rationale: based on the investigation, no additional investigation and no capa is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[179105373]
It was reported that during use the bd pen ndl 32g 4mm there was a needle stick injury. The following information was provided by the initial reporter: verbatim: ahs mdip report. Incident or problem information: ahs mdip reference number (id): (b)(4), date of incident (yyyy-mm-dd): (b)(6) 2020, site name/location: (b)(6) medical centre, level of harm: potential for harm, ahs optional report to cmdsnet (health (b)(4)): yes. Incident details: while using a bd sterile insulin needle (32g x 4mm with green cap), writer attempted to recap the needle after use. While recapping, the needle deflected off the inside of the cap, and then punctured the green safety cap. The writer did not notice that the needle had not recapped properly and when attempted to remove the needle from the pen a needle stick injury occurred. Upon inspection of the green cap the writer noticed that the design had been changed, and is now flared at the end, and this is likely what the needle deflected off of. Who was affected? Health care professional. Frequency of problem: first time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00068 |
| MDR Report Key | 9656250 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-02-01 |
| Date of Report | 2020-01-28 |
| Date of Event | 2020-01-11 |
| Date Mfgr Received | 2020-01-22 |
| Device Manufacturer Date | 2018-12-18 |
| Date Added to Maude | 2020-02-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BECTON DICKINSON AND CO. |
| Manufacturer Street | POTTERY ROAD |
| Manufacturer City | DUN LAOGHAIRE CO |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD PEN NDL 32G 4MM |
| Generic Name | PEN NEEDLE |
| Product Code | NSC |
| Date Received | 2020-02-01 |
| Catalog Number | 320555 |
| Lot Number | 8352806 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON AND CO. |
| Manufacturer Address | POTTERY ROAD DUN LAOGHAIRE CO |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-01 |