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

Catalog Number DP-40NS

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The facility has communicated that the device is not available for evaluation.An attempt to duplicate the failure mode was not made since at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.A device history review could not be conducted since the lot number was not provided.If the defective samples become available at a later date, this complaint will be updated accordingly.No corrective actions can be implemented and the customer complaint cannot be confirmed due to the lack of product sample and batch number to perform a proper investigation and determine the root cause.Teleflex will continue to monitor and trend related events.

Event Description

The complaint states: aortic punch would not fire; customer had to pull single sterile.There was no patient injury.

• Brand Name: PU DP-40K DISP PUNCH 4.0MMNS
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• 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 27560 ; 9194332672
• MDR Report Key: 6900735
• MDR Text Key: 87859751
• Report Number: 3004365956-2017-00354
• 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: 09/11/2017

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-40NS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2017
• Initial Date FDA Received: 09/28/2017
• 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