MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-23 for TC DE'BAKEY NDL HOLDER DEL SERR 305MM BM038R manufactured by Aesculap Ag.
[70902830]
(b)(4). Manufacturing site evaluation: evaluation on-going.
Patient Sequence No: 1, Text Type: N, H10
[70902831]
Country of complaint: (b)(6). It is reported that there is a gap or hole in the solder.
Patient Sequence No: 1, Text Type: D, B5
[75234166]
Investigation: the investigation was carried out using a keyence digital microscope. Batch history review: the device quality and manufacturing history records have been checked for the available lot numbers. The device history file has been checked and found to be according to our specification valid at the time of production. No similar incidents have been filed with products from this batch. Conclusion and root cause: based on the information available as well as a result of our investigation the root cause of the failure is most probably manufacturing error. Rational: the supplier quality manager confirmed that the needle holder is not according to the specifications. Corrective action: according to sop sa-de13-m-4-2-01-010 a capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610612-2017-00141 |
| MDR Report Key | 6430293 |
| Date Received | 2017-03-23 |
| Date of Report | 2017-04-25 |
| Date Facility Aware | 2017-03-06 |
| Date Mfgr Received | 2017-02-22 |
| Device Manufacturer Date | 2016-12-26 |
| Date Added to Maude | 2017-03-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TC DE'BAKEY NDL HOLDER DEL SERR 305MM |
| Generic Name | DUROGRIP NEEDLEHOLDERS |
| Product Code | HXK |
| Date Received | 2017-03-23 |
| Returned To Mfg | 2017-03-03 |
| Model Number | BM038R |
| Catalog Number | BM038R |
| Lot Number | 4508102494 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-23 |