MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-40K DISP PUNCH 4.0MM; INSTRUMENTS,SURGICAL,CARDIOVASCULAR

Catalog Number DP-40K

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.The device expected to be returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The doctor was utilizing the punch for a coronary artery bypass.He punched the artery and it worked as expected.When trying subsequent punches, the dp-40k punch was sticking and they had to open another punch to continue with the additional punches to complete the case.The patient's condition was reported as fine.

• Brand Name: PU DP-40K DISP PUNCH 4.0MM
• Type of Device: INSTRUMENTS,SURGICAL,CARDIOVASCULAR
• 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, NC 27560 ; 9194332672
• MDR Report Key: 5813759
• MDR Text Key: 50180858
• Report Number: 3004365956-2016-00281
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/11/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2021
• Device Catalogue Number: DP-40K
• Device Lot Number: 74D1601538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2016
• Initial Date FDA Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• 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