MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-16 for TC DE'BAKEY NEEDLE HOLDER 150MM BM032R manufactured by Aesculap Ag.
[114545051]
(b)(4). Manufacturing site evaluation: the instruments are not available for investigation. Only photos are available for the investigation. The instruments were washed once and now show corrosion damaged. According to the available information, there were no negative consequences for patient. The photos showed found reddish-brown corrosion spots. The product does not require batch management; a review of the quality and manufacturing history records is not possible. The root cause of the problem is most probably reposing or maintenance related. According to the quality standard a material defect and production error can be excluded. The discoloration are pinprick-like corrosion holes surrounded by sparkling, reddish-brown or multi-colored corrosion spots, often associated with circular corrosion deposits around the corrosion hole. The following points could be the cause of this: exposure due to halide ions, dried-on organic residues, frequent pitting is due to the use of liquids, brand new instruments are particularly layer. A capa is not necessary.
Patient Sequence No: 1, Text Type: N, H10
[114545052]
Country of complaint: (b)(6). It was reported that there was corrosion after sterilization.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00279 |
| MDR Report Key | 7691923 |
| Date Received | 2018-07-16 |
| Date of Report | 2018-07-16 |
| Date Facility Aware | 2018-06-19 |
| Date Mfgr Received | 2018-05-08 |
| Device Manufacturer Date | 2017-12-17 |
| Date Added to Maude | 2018-07-16 |
| 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 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 | 0 |
| Brand Name | TC DE'BAKEY NEEDLE HOLDER 150MM |
| Generic Name | DUROGRIP NEEDLEHOLDERS |
| Product Code | HXK |
| Date Received | 2018-07-16 |
| Returned To Mfg | 2018-05-17 |
| Model Number | BM032R |
| Catalog Number | BM032R |
| Lot Number | 4509173237 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 7 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 | 2018-07-16 |