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

Model Number IPN028441

Device Problem Unsealed Device Packaging (1444)

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

Event Date 02/01/2021

Event Type  malfunction  

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 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
• Type of Device: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 11635365
• MDR Text Key: 244471286
• Report Number: 3004365956-2021-00144
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 14026704631220
• UDI-Public: 14026704631220
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2021
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2021
• 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: N
• Patient Sequence Number: 1