MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-30 for RANEY SCALP CLIP FCPS 20-5115 manufactured by Codman & Shurtleff, Inc..
[66360252]
(b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[66360253]
As reported by the ous affiliate, dust was found in a sealed pack of raney forceps during the product inspection. Occurred before use on patient. As reported by the ous affiliate, the contamination was reported inside the sterile barrier.
Patient Sequence No: 1, Text Type: D, B5
[66369635]
Upon completion of the investigation, it was noted that the returned instrument was returned inside the original closed plastic bag. Evaluation of the returned product confirmed the complaint; there is loose foreign material (black specks) inside the plastic bag. However, this instrument is a non-sterile product and is sterilized prior to use on patient. Therefore; the particulates would not cause harm to the patient. The package (containing the particles) is open and discarded prior to sterilizing the instrument for use. If there are any particles on the instrument it is likely particles would be removed during the hospitals sterilization process. The complaint of? Dust was found in a sealed pack of raney forceps" was confirmed and is associated with packaging processes. It appears that this product was packaged in (b)(4). The packaging team ((b)(4) facility) was notified of this complaint and photos were submitted for review. Based on the results of this investigation, no further action is required. Trends will be monitored for this and similar complaints. At the present time this complaint is closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2017-10071 |
| MDR Report Key | 6286583 |
| Date Received | 2017-01-30 |
| Date of Event | 2017-01-18 |
| Date Mfgr Received | 2017-01-31 |
| Date Added to Maude | 2017-01-30 |
| 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 CLIP FCPS |
| Generic Name | CLIPS, SCALP |
| Product Code | HBO |
| Date Received | 2017-01-30 |
| Returned To Mfg | 2017-01-25 |
| Catalog Number | 20-5115 |
| Lot Number | 1182012 |
| 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 | 2017-01-30 |