MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-01-27 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[36955032]
Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[36955033]
Loose particles detected by stock check (for lot# bh606) in (b)(6). There was no reported patient harm or delay in surgery greater than 30 minutes.
Patient Sequence No: 1, Text Type: D, B5
[39853238]
Additional information: the device was returned and evaluated by the supplier. The supplier's evaluation confirmed that there was very slight debris within the pouch. The supplier indicated a potential cause to be related to static, which may have caused debris to cling to the bag. A review of manufacturing records was performed and no inconsistencies were noted when the device was released to stock. Operators have been made aware of the issue, and additional steps have been taken to reduce and detect particulates. Trends will be monitored for this or similar complaints. At present, we consider this complaint to be closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2016-10093 |
| MDR Report Key | 5394204 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-01-27 |
| Date Mfgr Received | 2016-02-05 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RANEY SCALP CLIPS |
| Generic Name | CLIPS, SCALP |
| Product Code | HBO |
| Date Received | 2016-01-27 |
| Returned To Mfg | 2016-01-20 |
| Catalog Number | 20-1037 |
| Lot Number | BH606 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF, INC. |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-27 |