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

Model Number	IPN028441
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74j2002445 that belong to catalog number a-4301-08lf pe pneumonectomy lf 6/cs has been reviewed and no issues or discrepancies were found which could potentially be related 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 and inspected according to our specifications.
Event or Problem Description
Customer reported that the seal to the product packaging is not closed.It is the individual packaging of each product.The products are not sterile.Clinical consequences: none.Incoming inspection/inventory review.

• Brand Name: PE PNEUMONECTOMY LF 6/CS
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11635386
• Report Number: 3004365956-2021-00145
• Device Sequence Number: 3396756
• Product Code: KDQ
• UDI-Device Identifier: 14026704631220
• UDI-Public: 14026704631220
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 03/23/2021

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?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1