MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2020-03-20 for BD ULTRA-FINE? NANO? PEN NEEDLES 4MM (5/32?) 32G 2865 320122 manufactured by Becton Dickinson And Co..
[186307872]
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred. Severity: s_1__; occurrence: a complaint history check was performed and this is the 5th related complaint for needle clog on lot # 7319668. 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 conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications. Investigation conclusion: 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. 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 at this time as the issue is unconfirmed as no samples or photos were returned. Rationale: based on the investigation, no additional investigation and no capa is required at this time.
Patient Sequence No: 1, Text Type: N, H10
[186307873]
It was reported that an unspecified number of bd ultra-fine? Nano? Pen needles 4mm (5/32? ) 32g were unable to deliver insulin/medication during use. The following information was provided by the initial reporter: material no: 320122 batch no: 7319668. Verbatim: unable to reach the consumer mentioned due to privacy guidelines. No additional information at this time and no one to follow up with. Reached to the pharmacy that reported the complaint. It is a call center and the representative that picked up the call, is not able to locate the representative that reported it. Supplied phone number to bd, just in case person is located. I received a call from a customer who stated "they were advised by the end user "insulin was not coning out when they tried to use the product. Lot number provided 7319668.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616656-2020-00249 |
| MDR Report Key | 9862331 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-10 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2017-11-15 |
| Date Added to Maude | 2020-03-20 |
| 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 ULTRA-FINE? NANO? PEN NEEDLES 4MM (5/32?) 32G |
| Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-20 |
| Model Number | 2865 |
| Catalog Number | 320122 |
| Lot Number | 7319668 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2020-03-20 |