MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2014-12-23 for RANEY SCALP CLIPS 20-1037 manufactured by Codman & Shurtleff, Inc.
[5179384]
It was found that the sterile pouch of the device had already been opened. There were no adverse consequences to the patient.
Patient Sequence No: 1, Text Type: D, B5
[12725567]
(b)(4). Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[32708257]
Upon completion of the investigation it was noted that we received disposable scalp clips in a sealed plastic pouch, see attached photograph. However, the sterile outer pouch was not returned. Without the sterile outer ouch it is not possible to verify the complaint of "sterile pouch of the device had already been opened". It is not possible to determine if the pouch was open in the clinical setting or if it was sent to the customer open. During manufacturing/packaging processes the packaging/product condition is examined prior to releasing the product in inventory. Therefore, it is unlikely that the package would have been released to inventory and shipped to the customer in the open condition. No root cause could be determined. 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 | 1226348-2014-12158 |
| MDR Report Key | 4358147 |
| Report Source | 01,07 |
| Date Received | 2014-12-23 |
| Date of Event | 2014-12-09 |
| Date Mfgr Received | 2015-01-08 |
| Date Added to Maude | 2014-12-23 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR JAMES KENNEY |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088282726 |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02767 |
| 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 | 2014-12-23 |
| Returned To Mfg | 2014-12-23 |
| Catalog Number | 20-1037 |
| Lot Number | HF603 |
| 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 | 1. Required No Informationntervention | 2014-12-23 |