MAUDE Adverse Event Report: TELEFLEX MEDICAL COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I; INSTRUMENT, LIGATURE PASSING A

Catalog Number EFX002

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/22/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaints voided and retracted: mfr#3006425876-2019-00186, mfr#3011137372-2019-00145.The initial mdr report was mistakenly submitted under mfr#3006425876-2019-00186 ((b)(4)).A follow-up report was resubmitted under 3011137372-2019-00145, ((b)(4)) however; the report could not be submitted due to system error.Both mfr#3006425876-2019-00186 and mfr#3011137372-2019-00145 are voided and to be retracted.Correct mfr#3011137372-2019-00201 (initial and follow-up report): the attached new complaint was created with the correct information: 3011137372-2019-00201 ((b)(4)).Details of the initial and follow-up report: no evaluation of the device or dhr review can be performed as the device was not returned and no lot number provided.Therefore, the complaint cannot be verified or valid.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that once the thread was inserted, the device broke when the surgeon removed the efx.The plastic cover on the upper part of the triangle broke.It was difficult to remove the device.There was no patient injury.

• Brand Name: COTTONY II DACRON, SILKY II POLYDEK & TEVDEK I
• Type of Device: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 8832572
• MDR Text Key: 152674119
• Report Number: 3011137372-2019-00201
• Device Sequence Number: 1
• Product Code: HCF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EFX002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/26/2019
• Initial Date FDA Received: 07/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1