MAUDE Adverse Event Report: TELEFLEX MEDICAL PE ADULT-PED DRY/ WET LF 6/CS; BOTTLE, COLLECTION, VACUUM

Catalog Number A-6000-08LF

Device Problem Leak/Splash (1354)

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

Event Date 01/30/2023

Event Type  malfunction  

Event Description

Reported issue: we observed a leak on the section of the tube between the chamber and the red connector.The device was replaced and there was no injury.

Manufacturer Narrative

Qn#(b)(4).The device history record of batch number 74j2201060 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 and inspected according to our specifications.

• Brand Name: PE ADULT-PED DRY/ WET 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: 16430991
• MDR Text Key: 310174594
• Report Number: 3004365956-2023-00008
• Device Sequence Number: 1
• Product Code: KDQ
• 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,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74J2201060
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/12/2022
• 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
• Treatment: NONE REPORTED