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

Model Number IPN028442

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device history record of batch number 74f2000964 that belong to catalog number a-6000-08lf (pe adult-ped dry/ wet lf) 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.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

There was an abnormal bubbling (not due to patient) that happened with 5 pleur-evac with 5 different patients.There is a leak at the level between the removable drain tube and the plug in the pleur-evac chamber.We figured it out by clamping the drain and there was still bubbling while clamped.We solved the leak issue by doing multiple connections-disconnections-reconnections of this tubing in the pleur-evac until the abnormal bubbling stopped.All current condition of the 5 patients are stable.There is an increase of the time spent in the hospital due to the abnormal bubbling on the drain circuit.All the 5 pleur-evac are still used in the patients in situ.

• Brand Name: PE ADULT-PED DRY/ WET LF
• 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: 11399565
• MDR Text Key: 234785805
• Report Number: 3004365956-2021-00074
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• 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
• Reporter Occupation: Risk Manager
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2023
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74F2000964
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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