MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-06-26 for 1392 5.9MM STRYKER SHEATH 2 WAY -NS 281392 manufactured by Depuy Mitek Llc Us.
[112434387]
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate. Evaluation statement the complaint device was received and evaluated. Visual observations reveal that all components on the returned sheath are intact and there are no loose or broken parts. The screws below the inflow/ outflow valves were disassembled to check for any wear that would cause this failure. It appears that on one valves, the threads are worn and corroded possibly from the repeated use & sterilization cycles. When assembled, the fixture is tight and allows the valves to move without loosening. The screws are able to hold the valves tightly in position without any discrepancies as reported in the complaint. We cannot confirm this complaint at this point. A batch record review has been conducted and our results indicate that this batch of product was processed without incident and therefore there is no internally assignable cause for the reported problem. Further, a review into the mitek complaints system revealed no other complaints of any kind for this lot of devices released for distribution. At this point in time, no corrective action is required and no further action is warranted. However, depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field. (b)(4). This report is being filed from the remetrex complaint management system as required under mitek's corrective and preventative actions (capa) to file usa fda mdr missed malfunctions.
Patient Sequence No: 1, Text Type: N, H10
[112434388]
The sales representative reported the screws on the customer's high flow sheath broke off below the inflow/outflow valve during an unknown procedure. He stated he was not present during the case but verified that nothing fell inside the patient. The surgeon used another like device to complete the procedure with no patient consequences or delays. The device is being returned. No further information could be provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221934-2018-51104 |
| MDR Report Key | 7638335 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-06-26 |
| Date of Report | 2013-04-26 |
| Date Mfgr Received | 2013-04-26 |
| Device Manufacturer Date | 2010-05-31 |
| Date Added to Maude | 2018-06-26 |
| 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 | OTHER CAREGIVERS |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JENNIFER LAWRENCE |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA 02767 |
| Manufacturer Country | US |
| Manufacturer Postal | 02767 |
| Manufacturer Phone | 5088808100 |
| Manufacturer G1 | DEPUY MITEK LLC US |
| Manufacturer Street | 325 PARAMOUNT DRIVE |
| Manufacturer City | RAYNHAM MA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 1392 5.9MM STRYKER SHEATH 2 WAY -NS |
| Generic Name | RIGID ENDOSCOPE SHEATH |
| Product Code | HNX |
| Date Received | 2018-06-26 |
| Returned To Mfg | 2013-05-13 |
| Catalog Number | 281392 |
| Lot Number | 44666008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEPUY MITEK LLC US |
| Manufacturer Address | 325 PARAMOUNT DRIVE RAYNHAM MA 02767 US 02767 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-26 |