MAUDE Adverse Event Report: TELEFLEX MEDICAL MDK VI MF 0 TC43/HR26 48"; SUTURE, SURGICAL, ABSORBABLE,

Catalog Number	833-137
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "first, a polypropylene 36in suture was used - it broke down to pieces (inside the patient) after tightening.The physician then decided to use monodek suture instead to finish the procedure.While unpacking the monodek and catching it with a "mosquito", it broke from needle separated from the suture and the suture broke down to small pieces with every touch.This happened 3 times while unpacking monodek sutures of the same box.The 4th monodek suture that was opened was ok and good for use, so the doctor finished the procedure and patient was released after a night of hospitalization for observation".No patient harm or injury.The patient status is reported as "fine".See associated mdrs 3004365956-2025-00068, 3004365956-2025-00069, 3004365956-2025-00071.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.
Event or Problem Description
It was reported that "first, a polypropylene 36in suture was used - it broke down to pieces (inside the patient) after tightening.The physician then decided to use monodek suture instead to finish the procedure.While unpacking the monodek and catching it with a "mosquito", it broke from needle separated from the suture and the suture broke down to small pieces with every touch.This happened 3 times while unpacking monodek sutures of the same box.The 4th monodek suture that was opened was ok and good for use, so the doctor finished the procedure and patient was released after a night of hospitalization for observation".No patient harm or injury.The patient status is reported as "fine".See associated mdrs 3004365956-2025-00068, 3004365956-2025-00069, 3004365956-2025-00071.
Additional Manufacturer Narrative
(b)(4) one unit of catalog number was received for evaluation.Sample was not received in its original packaging.While performing the visual inspection test it was observed that the suture was get-ting disintegrated (broke down to small pieces), as it is described in this customer complaint, it was also noted that the sample was incomplete as it did not contain the hr23 needle or the tc-43 bullet.A dimensional inspection of the product involved in the complaint could not be con-ducted since the product returned was received disintegrated.A functional inspection test cannot be performed on the received sample since it was received disintegrated, and no functional test can be performed in this condition.Additionally, an attempt to duplicate the failure mode was made but at the time there is no inventory of the product code available.The device history rec-ord of batch number has been reviewed, and no issues or discrepancies were found which could potentially be related to this complaint.While performing the visual inspection test it was observed that the suture was getting disinte-grated, what the customer is reporting as suture broke down into small pieces, is a disintegration of the suture.Even though a disintegration issue was observed in the received sample it is not possible to confirm that this condition was generated during the manufacturing process.Addi-tionally, the timeline of this batch was reviewed, and all timing specifications were met.Accord-ing to the warnings section of ifu, the product must be stored at room temperature and pro-longed exposure to high temperatures must be avoided.It is unknown the storage conditions the product was subjected to after the product was shipped from teleflex.As part of the activities of this evaluation, personnel from the manufacturing process were notified for awareness of this complaint report.Additionally, as a preventive action supplier of the involved suture was notified to make them aware of this issue, and the sister facility were the final packaging is performed was also notified of this event for awareness.This complaint file will be updated if additional information is received.Complaints of this type will continue to be monitored.Other remarks: n/a corrected data: n/a.

• Brand Name: MDK VI MF 0 TC43/HR26 48"
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE,
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23896628
• Report Number: 3004365956-2025-00070
• Device Sequence Number: 5329791
• Product Code: NEW
• UDI-Device Identifier: 14026704603920
• UDI-Public: (01)14026704603920(11)230216(17)260202(10)74B2300028(21)
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K030212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/02/2026
• Device Catalogue Number: 833-137
• Device Lot Number: 74B2300028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 01/16/2026
• Initial Report FDA Received Date: 12/26/2025
• Supplement Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown