MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULED ADULT RECHARGEABLE BATTERY; BATTERY, RECHARGEABLE

Catalog Number 0055502

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

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.

Manufacturer Narrative

(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.

Event Description

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.

• Brand Name: RUSCH TRULED ADULT RECHARGEABLE BATTERY
• Type of Device: BATTERY, RECHARGEABLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5768705
• MDR Text Key: 48728273
• Report Number: 3011137372-2016-00190
• Device Sequence Number: 1
• Product Code: FCO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 0055502
• Device Lot Number: 1451V3
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1