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 03/02/2021

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).A visual nor functional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.The device history record of batch number 74g2000459 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.The device history review shows that the product was assembled and inspected according to our specifications.The root cause is undetermined-no sample.The customer complaint cannot be confirmed based only on the information provided, to perform an investigation and determine the source of defect reported it is necessary to evaluate the sample involved on this complaint.However, material from the production line was verified and no issues were found that can lead to this customer complaint.If the sample becomes available this investigation will be updated with the evaluation results.Teleflex will continue to monitor and trend related events.

Event Description

The hospital faced 4 different incidents with 4 different pleur-evac.There was a leak at the level of letter "e" of the picture.It was bubbling at the "e" chamber despite a clamp (using "j" clamp) performed at the level between letters "i" and "l" on the tubing.Clinical consequence: the device was changed with success.It happened only with lot# 74g2000459.Additional information received: customer made an amendment about the location of the leak.Involved a patient who was in the thoracic surgery department because of an intervention by thoracotomy.The staff observed that there was a leak at the level of the red and blue ats connector.Clinical consequence: there was a delay in the treatment.There was no patient consequence.

• 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: 11567587
• MDR Text Key: 251697442
• Report Number: 3004365956-2021-00097
• 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
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74G2000459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2020
• 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