MAUDE Adverse Event Report: TELEFLEX MEDICAL MDK VI MF 0 TC-43/HR26 48"; SUTURE, SURGICAL, ABSORBABLE,

Catalog Number 833-137LP

Device Problems Break (1069); Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A functional inspection of the product involved in the complaint could not be conducted since the product was not returned.A complaint history review was conducted on the catalog number in question.No complaints were received in this range with the same issue.The device history record of batch number provided has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Corrective actions cannot be established, the customer complaint cannot be confirmed, and the root cause cannot be determined since it is necessary to receive the physical sample to perform a proper investigation and to confirm the alleged defect.If the alleged defective samples become available at a later date, this complaint will be updated accordingly.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that the capio got stuck.Then the capio bullet broke off in the patient.There is no reported injury to the patient.

• Brand Name: MDK VI MF 0 TC-43/HR26 48"
• Type of Device: SUTURE, SURGICAL, ABSORBABLE,
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 7820241
• MDR Text Key: 118537046
• Report Number: 3004365956-2018-00245
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K030212
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Catalogue Number: 833-137LP
• Device Lot Number: 74D1700590
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Weight: 62