MAUDE Adverse Event Report: TELEFLEX MEDICAL PU MDP-40K DISP PUNCH 4.0MM; INSRTUMENT,SURGICAL,NON-POWERED

Catalog Number MDP-40K

Device Problem Mechanical Jam (2983)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.The manufacturer will continue to monitor and trend related events.

Event Description

The device sticks after engaging and did not release.The patient's condition was reported as fine.

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.(b)(4) was issued for another issue non-related to this customer complaint.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility nor is being manufactured at the time.No corrective actions can be implemented due the lack of product sample to perform a proper investigation and determine the root cause.Customer complaint cannot be confirmed due the lack of product sample to perform a proper investigation and determine the root cause.

Event Description

The device sticks after engaging and did not release.The patient's condition was reported as fine.

• Brand Name: PU MDP-40K DISP PUNCH 4.0MM
• Type of Device: INSRTUMENT,SURGICAL,NON-POWERED
• 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: 6042042
• MDR Text Key: 57919984
• Report Number: 3004365956-2016-00387
• 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,Followup
• Report Date: 10/11/2016

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: 02/18/2020
• Device Catalogue Number: MDP-40K
• Device Lot Number: 74B1501365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2016
• Initial Date FDA Received: 10/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2015
• 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