MAUDE Adverse Event Report: TELEFLEX MEDICAL PU DP-44K DISP PUNCH 4.4MM; INSTRUMENTS, SURGICAL, CARDIOV

Model Number IPN915271

Device Problems Entrapment of Device (1212); Separation Failure (2547)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/20/2022

Event Type  Injury  

Manufacturer Narrative

Qn#: (b)(4).The investigation is pending.

Event Description

20 year-old female patient, 76kg.Incident happened on (b)(6) 2022 in the surgery room.During the intervention, we used the aortic punch on the artery to make the anastomosis.After using it, the device did not cut the artery properly and it got stuck on the artery.There was a serious consequence because the surgeon had to cut the artery with the scalpel to remove the aortic punch.The orifice of the artery not being circular, the surgeon had to redo the anastomosis.

Event Description

20 year-old female patient, 76kg.Incident happened on 20 may 2022 in the surgery room.During the intervention, we used the aortic punch on the artery to make the anastomosis.After using it, the device did not cut the artery properly and it got stuck on the artery.There was a serious consequence because the surgeon had to cut the artery with the scalpel to remove the aortic punch.The orifice of the artery not being circular, the surgeon had to redo the anastomosis.

Manufacturer Narrative

(b)(4).The device history record of batch number 74e2100822 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non conformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled & inspected according to our specifications.No corrective action can be established at this moment since the product sample is not available for evaluation.Product sample is necessary to perform a proper investigation to determinate the root cause and the corresponding corrective actions.Customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this 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 neither is being manufactured at the time.If defective sample becomes available at a later date this complaint will be updated as applicable.

• Brand Name: PU DP-44K DISP PUNCH 4.4MM
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOV
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville 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: 14829701
• MDR Text Key: 294780614
• Report Number: 3004365956-2022-00043
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915271
• Device Catalogue Number: DP-44K
• Device Lot Number: 74E2100822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Weight: 76 KG