MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2012-08-28 for CODMAN* DISPOS VEIN STRIP 63-4031 manufactured by Codman And Shurtleff - Raynham.
[2995854]
The affiliate reported that the vein stripper was loaded and the button applied. The surgeon began pulling the stripper through the vein when, mid procedure, the end released in the vein. Surgeon then used ultrasound to locate the piece and a small surgical incision was made to retrieve it. Device will be forwarded on receipt.
Patient Sequence No: 1, Text Type: D, B5
[10215531]
Upon completion of the investigation a follow up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[10435102]
Upon completion of the investigation it was noted that the evaluation did not reveal a true root cause for failure. The device was visually inspected through the pouch as the device was not properly decontaminated. When viewing the device through the pouch, nothing out of the ordinary was noted. The cord contains the grooves, which is designed to allow the tip to be securely molded. In addition, during the manufacturing process, when the tips are molded to the cord, each unit is subjected to an auto pull test. A review of the device history records confirmed that the device conformed to the required specifications prior to distribution. 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 | 1226348-2012-00430 |
| MDR Report Key | 2718185 |
| Report Source | 01,07 |
| Date Received | 2012-08-28 |
| Date Mfgr Received | 2012-09-25 |
| Date Added to Maude | 2012-08-28 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR MATTHEW KING |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CODMAN* DISPOS VEIN STRIP |
| Generic Name | STRIPPER, VEIN, DISPOSABLE |
| Product Code | GAJ |
| Date Received | 2012-08-28 |
| Returned To Mfg | 2012-08-23 |
| Catalog Number | 63-4031 |
| Lot Number | LD609 |
| 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 AND SHURTLEFF - RAYNHAM |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-08-28 |