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

Catalog Number DP-40K

Device Problem Misfire (2532)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/27/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number was not provided.The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

During a cardiac procedure the device misfired.There was no patient injury.

Manufacturer Narrative

(b)(4).A dhr review could not be conducted since the lot number was not provided.A visual inspection was performed to 1 piece from product code dp-40k (pu dp-40k disp punch 4.0mm) which was received as part of this complaint, piece is received jammed and contains blood residues in the tip; this sample was not received in its original packaging.Dimensional testing according to qa-pun-001/f2 & f3 was performed to the metal components once disassembled obtaining acceptable dimensional results.As an additional activity, the instructions for use 151894mx applicable to the product code dp-40k was reviewed.As part of the warnings, the following indication is shown: "remove the excised tissue before additional openings are created".Following this warning avoids the user to have a functional failure caused by blood residues and tissue.As an additional activity, the instructions for use 151894mx applicable to the product code dp-40k was reviewed.As part of the warnings, the following indication is shown: "remove the excised tissue other remarks: before additional openings are created".Following this warning avoids the user to have a functional failure caused by blood residues and tissue.Customer complaint is not confirmed since the sample received was found to be within the dimensional requirements, however, sample couldn't be triggered since it was already caught with blood residues.Although the condition reported is observed based on the sample provided, there is no sufficient evidence to assure that this issue was originated during the manufacturing process.

Event Description

During a cardiac procedure the device misfired.There was no patient injury.

• Brand Name: PU DP-40K DISP PUNCH 4.0MM
• Type of Device: INSTRUMENTS,SURGICAL,CARDIOVASC
• 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: 6699031
• MDR Text Key: 79644913
• Report Number: 3004365956-2017-00283
• 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: 06/28/2017

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-40K
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/10/2017
• Supplement Dates Manufacturer Received: 02/12/2018
• Supplement Dates FDA Received: 02/20/2018
• 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