MAUDE Adverse Event Report: TELEFLEX MEDICAL DURAHOOK 1/4 HOOK

Catalog Number 382800

Device Problem Degraded (1153)

Patient Problem Not Applicable (3189)

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review for the product durahook 1/4 hook 10 pkg/bx 6 hks/pkg, lot number 73m1400048 did not show issues related to the complaint.The device sample has not been returned to the manufacturer for investigation at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the durahooks are dry rotting which is evident through the packaging.There was no patient involvement.

Manufacturer Narrative

(b)(4).One (1) pouch from p/n 382800 durahook 1/4 hook (b)(4) was received not used , closed in original packaging, lot # 73m1400048 was confirmed with received sample, during visual inspection components looked well assembled, rubber bands did not appear to have damage.Functional inspection: pouch was opened to review the rubber bands conditions (undamaged), then rubber bands were fastened to a paperboard, after rubber bands were stretched to full capacity , no quality issues were found during functional testing (rubber bands were not broken), therefore failure mode dry rot reported by customer was not able to be duplicated.Sample received did not confirm the defect reported by the customer "dry rot." a functional inspection was performed and the device worked properly; not broken.Therefore, a corrective action is not required at this time.However, we will continue to monitor trending of similar complaints.

Event Description

Alleged event: the durahooks are dry rotting which is evident through the packaging.There was no patient involvement.

• Brand Name: DURAHOOK 1/4 HOOK
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4952602
• MDR Text Key: 22565852
• Report Number: 3003898360-2015-00546
• Device Sequence Number: 1
• Product Code: GDG
• 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,health
• Reporter Occupation: Other
• Report Date: 07/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/12/2016
• Device Catalogue Number: 382800
• Device Lot Number: 73M1400048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2014
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1