MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-48K DISP PUNCH 4.8MM

Catalog Number DP-48K

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.No rejection report was originated for the lot in question that can be associated to the complaint reported.The device history review shows that the product was assembled and inspected according to our specifications.The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during a kidney transplant it was intended to take a tissue sample.During the attempt to remove the tissue sample the disposable aorta punch jammed and could not be triggered 100%.The product was unfortunately disposed of, a representative product with the same lot will be returned.There was no reported patient injury.

Manufacturer Narrative

(b)(4).Visual inspection was performed to 1 piece from product code (b)(4) received as part of this complaint, sample was received in their corresponding wrapping (pouch) and sealed pouch.Dimensional tests according to qa-pun-001/f2 and f3 were performed obtained acceptable results in core and blade parts.Functional test was performed according to qa-pun-003/f1 to the unit obtaining acceptable results.No corrective actions can be established since the dimensional and functional test demonstrated that product is according to specification.Customer complaint is not confirmed due the dhr reviewed showed that there were no issues related to the reported failure mode neither on the product or its components during the manufacture of this material also closed sample received demonstrated are according to specifications.Results - no result code available that could accurately describe that the complaint was confirmed, but the root cause is unknown.

Event Description

It was reported that during a kidney transplant it was intended to take a tissue sample.During the attempt to remove the tissue sample the disposable aorta punch jammed and could not be triggered 100%.The product was unfortunately disposed of, a representative product with the same lot will be returned.There was no reported patient injury.

• Brand Name: PU DP-48K DISP PUNCH 4.8MM
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6979735
• MDR Text Key: 90579145
• Report Number: 3004365956-2017-00373
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2017

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 Catalogue Number: DP-48K
• Device Lot Number: 74D1702443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2017
• Initial Date FDA Received: 10/26/2017
• Supplement Dates Manufacturer Received: 11/20/2017
• Supplement Dates FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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