MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-05-15 for HOFF PASS-LONG 82-1716 manufactured by Codman & Shurtleff.
[4529042]
Customer reported that shunt passer sheath is defective and metal on metal friction has resulting in metal shavings. No patient injury as result of defect. We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013. Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files. The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures. Please refer to complaint (b)(4). An initial is being generated reclassifying the event to a serious injury.
Patient Sequence No: 1, Text Type: D, B5
[11891529]
We recently revised our mdr reporting procedures based on feedback from a recent fda audit that was conducted in 2013. Once the changes were made to the procedures, we conducted retrospective review of our product complaints and mdr files. The attached mdr report is being filed as result of those changes we made to our internal mdr reporting procedures. Please refer to complaint (b)(4). An initial is being generated reclassifying the event to a serious injury. Upon completion of the investigation, it was noted that the evaluation of the instrument revealed excessive wear throughout. The passer was very tight within the sheath and was difficult to remove. Excessive friction was felt when removing the passer and caused the metal to scrape. The sheath is bent not allowing for proper fit of the passer. It is likely that manipulation of the sheath over time resulted in bending/poor fit. The date of manufacture (or another marking) is not visible, however; instrument appears to be old. Trends will be monitored for this and similar complaints. At the present time this complaint is considered closed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1226348-2014-11630 |
| MDR Report Key | 3812878 |
| Report Source | 07 |
| Date Received | 2014-05-15 |
| Date Mfgr Received | 2014-05-14 |
| Date Added to Maude | 2014-05-15 |
| 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 | HOFF PASS-LONG |
| Generic Name | INSTRUMENT, SHUNT SYSTEM IMPLANTATION |
| Product Code | GYK |
| Date Received | 2014-05-15 |
| Returned To Mfg | 2012-04-09 |
| Catalog Number | 82-1716 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CODMAN & SHURTLEFF |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-05-15 |