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 2017-04-04 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc..
[72943663]
(b)(4). Possible lot numbers: kg610, ej608, ej612, gj600, or ej606. Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[72943664]
It was reported from distributor, (b)(6), that it was found a foreign material (white pellet) inside of a package of 20-1037 delivered from (b)(6). This was detected during the repacking process at (b)(6) on (b)(6) 2017. The suspected lot number was one of kg610, ej608, ej612, gj600, or ej606. There was no surgical delay and no adverse consequences to the patient. No further information was provided by the customer.
Patient Sequence No: 1, Text Type: D, B5
[73854515]
The device has been returned for evaluation. Upon completion of the investigation, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[74802223]
A bag of clips was returned for evaluation. It was confirmed that there was a white pellet in the bag. A review of the potential lots provided was performed and no discrepancies were found. The supplier's evaluation of the returned pouch found what appeared to be a bead of resin (raw material) used in the molding process. During molding the clips fall into a bin, which are then inspected/packaged for bagging at a later time. The clips are then bagged/sealed in counts of 10, to be pouched into the final tyvex pouch. This stray bead of resin (raw material) may have carried thru due to static. Based on the supplier's evaluation, the reported issue was confirmed. A review of complaint records did not find any similar complaints against any of the potential lots provided. 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 | 1226348-2017-10230 |
| MDR Report Key | 6456454 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-04-04 |
| Date of Event | 2017-03-15 |
| Date Mfgr Received | 2017-04-18 |
| Date Added to Maude | 2017-04-04 |
| 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 | 2017-04-04 |
| Returned To Mfg | 2017-03-29 |
| Catalog Number | 20-1037 |
| Lot Number | SEE ADDITIONAL INFORMATION |
| 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 | 2017-04-04 |