MAUDE Adverse Event Report: TELEFLEX MEDICAL PILLING AORTIC PUNCH, STD TIP, 3.5; INSTURMENTS,SURGICAL,CARDIOVASCULAR

Catalog Number 353435

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2015

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 sample investigation report has not been submitted at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the punch did not cut cleanly.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4) sample from product code (b)(4) was received as part of this complaint, sample is not in it original packaging and appears used with several sections rusty.A dimensional inspection was performed using the form (b)(4) obtained in all dimensions that produced acceptable results.Functional inspection cannot be performed based in rusty condition of sample.No corrective actions can be implemented, and customer complaint cannot be confirmed since the sample that was received met tolerances and parameters established.Sample demonstrated be in accordance with all quality specifications: (b)(4).The manufacturer will continue to monitor and trend similar complaints.

Event Description

Alleged event: the punch did not cut cleanly.The patient's condition was reported as fine.

• Brand Name: PILLING AORTIC PUNCH, STD TIP, 3.5
• Type of Device: INSTURMENTS,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: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5208059
• MDR Text Key: 30638123
• Report Number: 3004365956-2015-00323
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Catalogue Number: 353435
• Device Lot Number: 74G1402459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/25/2014
• 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