MAUDE Adverse Event Report: TELEFLEX MEDICAL DEK BL MF 0 TC-43/HR26 2N 36" BSC; DEKLENE MAXX POLYPROPELENE NON

Model Number	IPN056767
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).No issues or discrepancies were found in the device history record of product code 833-235, batch 74h2101195, that can be related to the failure mode reported.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Reported event: taper cut needle broke off.No health consequences or impact.

• Brand Name: DEK BL MF 0 TC-43/HR26 2N 36" BSC
• Common Device Name: DEKLENE MAXX POLYPROPELENE NON
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville 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: 16369030
• Report Number: 3004365956-2023-00006
• Device Sequence Number: 7544219
• Product Code: GAW
• UDI-Device Identifier: 14026704735324
• UDI-Public: 14026704735324
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K153076
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/16/2023

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: 08/11/2026
• Device Model Number: IPN056767
• Device Catalogue Number: 833-235
• Device Lot Number: 74H2101195
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 02/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2021
• 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: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown