MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-44K DISP PUNCH 4.4MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number IPN915271

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  malfunction  

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.

Event Description

It was reported that "in the packaging there is a dp-40k punch whereas the label indicates the reference dp-44k.We only have one unit in stock for which we are experiencing this problem.The other units in stock are correct".No patient involvement.

Manufacturer Narrative

Qn#(b)(4).Customer complaint is confirmed, the unit has stamped an incorrect product number.One unit of catalog number dp-44k (pu dp-44k disp punch 4.4mm) with lot 74c2301895 was received for analysis.Sample was received in its original packaging sealed.The stamp applied directly on product denotes, "teleflex 4.0mm dp-40k" and the label lbl025013 r03 denotes dp-44k.A device history record review was performed, and no relevant findings were identified.An investigation was initiated to further investigate the issue.The investigation is still on-going.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that "in the packaging there is a dp-40k punch whereas the label indicates the reference dp-44k.We only have one unit in stock for which we are experiencing this problem.The other units in stock are correct".No patient involvement.

• Brand Name: PU DP-44K DISP PUNCH 4.4MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17663259
• MDR Text Key: 322622797
• Report Number: 3004365956-2023-00064
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 14026704697950
• UDI-Public: 14026704697950
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN915271
• Device Catalogue Number: DP-44K
• Device Lot Number: 74C2301895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 10/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1