MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2016-07-05 for RUSCH TRULED ADULT RECHARGEABLE BATTERY 0055502 manufactured by Teleflex Medical.
[48728273]
(b)(4). The device sample was not returned for evaluation at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
[48728274]
The customer alleges that the battery cartridge is broken. The end (metal pieces) that screws to the end of the handle is dislodged. The alleged issue was detected during pre-testing.
Patient Sequence No: 1, Text Type: D, B5
[52407498]
(b)(4). The sample was returned for evaluation. A visual exam was performed and it was observed that the threaded metal ring used to secure the cartridge into the handle was missing. The cartridge could not be seated safely and securely into the truled handle. The complaint has been confirmed. The defective condition could be the result of two scenarios. The first, over torquing (tightening) of the truled cartridge threaded retaining ring. The second, dropping the truled cartridge on a hard surface and dislodging the retainer ring. While a definitive reason for either of these scenarios cannot be assigned with the information provided, it should be noted that tightening of the threaded truled cartridge can be easily achieved by using reasonable hand force, and reasonable care should be taken to ensure the battery cartridges are not dropped. A conclusion code could not be chosen as the complaint was confirmed; however, a root cause could not be established.
Patient Sequence No: 1, Text Type: N, H10
[52407499]
The customer alleges that the battery cartridge is broken. The end (metal pieces) that screws to the end of the handle is dislodged. The alleged issue was detected during pre-testing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011137372-2016-00190 |
| MDR Report Key | 5768705 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2016-07-05 |
| Date of Report | 2016-06-17 |
| Date of Event | 2016-06-13 |
| Date Mfgr Received | 2016-07-28 |
| Date Added to Maude | 2016-07-05 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHARINE TARPLEY |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194334854 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27560 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH TRULED ADULT RECHARGEABLE BATTERY |
| Generic Name | BATTERY, RECHARGEABLE |
| Product Code | FCO |
| Date Received | 2016-07-05 |
| Returned To Mfg | 2016-07-14 |
| Catalog Number | 0055502 |
| Lot Number | 1451V3 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-07-05 |