MAUDE Adverse Event Report: TELEFLEX MEDICAL PE PNEUMONECTOMY LF 6/CS; BOTTLE, COLLECTION, VACUUM

Model Number IPN028441

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history review could not be conducted since the lot number provided (74j200245) is not a valid lot number at teleflex (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Defective packaging sealing with the compromise of sterility.

Manufacturer Narrative

Qn#(b)(4).The device history record of batch number 74j2002445 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance 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.Manufacture date: 2020-09-28.Expiration date: 2025-09-27.One unit of catalog number a-4301-08lf (pe pneumonectomy lf 6/cs) lot 4j2002445 was received for analysis.The sample was visually inspected , and it was observed marks of a weak seal on header bag (p/n tfx-000255).A nonconformance was opened to identify the root cause and corresponding corrective actions.Customer complaint is confirmed, the unit had open seal.During the visual inspection it was observed marks of a weak seal header bag (p/n tfx-000255).To properly address this issue a nonconformance (#(b)(4) ) was opened to identify the root cause and corresponding corrective actions.

Event Description

Defective packaging sealing with the compromise of sterility.

• Brand Name: PE PNEUMONECTOMY LF 6/CS
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12460522
• MDR Text Key: 272227063
• Report Number: 3011137372-2021-00235
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 14026704631220
• UDI-Public: 14026704631220
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028441
• Device Catalogue Number: A-4301-08LF
• Device Lot Number: 74J2002445
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• 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