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

Model Number	IPN028441
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Defective packaging sealing with the compromise of sterility.
Additional 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 or Problem Description
Defective packaging sealing with the compromise of sterility.

• Brand Name: PE PNEUMONECTOMY LF 6/CS
• Common Device Name: 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
• Report Number: 3011137372-2021-00235
• Device Sequence Number: 3375565
• Product Code: CAC
• UDI-Device Identifier: 14026704631220
• UDI-Public: 14026704631220
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/27/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 12/14/2021
• Initial Report FDA Received Date: 09/13/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown