MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-27 for BN MAR BIOP ASP NDL 8X4 LL X10 8881247087 manufactured by Covidien.
[37008305]
Submit date 01/27/2016. An investigation is currently under way; upon completion, the results will be forwarded. (b)(4)
Patient Sequence No: 1, Text Type: N, H10
[37008306]
It was reported to covidien on (b)(6) 2016 that a customer had an issue with a biopsy needle. The customer states during a bone biopsy procedure on anal cancer patient, the device handle broke off. The exposed portion of the needle was removed with pliers. No adverse patient outcome occurred related to this incident.
Patient Sequence No: 1, Text Type: D, B5
[38436244]
The device history record (dhr) of the lot number reported was reviewed, and it was confirmed that the products were produced accomplishing quality requirements and was released according to established procedures. No sample or picture was received for evaluation. Due to this, the customer complaint was not confirmed. The bone marrow item is not manufactured by the plant. This product is a pick-and-place product in the plant process. A supplier corrective action request (scar) was opened to follow up this issue and a corrective and preventative action (capa) was opened at the suppliers to determine root cause and corrective actions. At the plant, a quality alert was generated to notify incoming inspection and process personnel. A possible root cause could be related to lack of adhesive between the needle and the handle. This complaint will be used for tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2016-00012 |
| MDR Report Key | 5392605 |
| Date Received | 2016-01-27 |
| Date of Report | 2016-01-04 |
| Date of Event | 2015-11-20 |
| Date Mfgr Received | 2016-02-11 |
| Date Added to Maude | 2016-01-27 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE ST |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA |
| Manufacturer City | TIJAUNA |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BN MAR BIOP ASP NDL 8X4 LL X10 |
| Generic Name | BIOPSY NEEDLE |
| Product Code | OIJ |
| Date Received | 2016-01-27 |
| Model Number | 8881247087 |
| Catalog Number | 8881247087 |
| Lot Number | 143530348X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 37 BLVD. INSURGENTES LIBRIAMENTO A LA P, LA MESA TIJUANA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-27 |