MAUDE Adverse Event Report: TELEFLEX MEDICAL WECK EFX SHIELD PORT SITE CLOSURE SYSTEM; INSTRUMENT, LIGATURE PASSING A

Catalog Number EFX002

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/25/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the shield broke inside of a patient.

Manufacturer Narrative

(b)(4).The device itself could not be reviewed as it was not returned to bridgemedica for evaluation.A review of the dhr (lcn 3300650000} showed that this lot was sorted for this particular issue using the customer's sampling plan and acceptance criteria.While it is clear that the wing broke, the lot was sorted 100% and was determined to be acceptable by the customer's acceptance criteria.It should be noted that the customer's sampling plan differs from bridgemedica's typical acceptance sampling plan (aql=1.0~ c=o}.Therefore approximately this complaint is considered verified but not valid.

Event Description

It was reported that the shield broke inside of a patient.

• Brand Name: WECK EFX SHIELD PORT SITE CLOSURE SYSTEM
• Type of Device: INSTRUMENT, LIGATURE PASSING A
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8350044
• MDR Text Key: 136535004
• Report Number: 3011137372-2019-00050
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2020
• Device Catalogue Number: EFX002
• Device Lot Number: 3300650000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1