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

Model Number IPN028446

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/24/2022

Event Type  malfunction  

Event Description

It was reported that leakage was found between the red and blue fast click connector while using in patient.There was no reported injury.

Manufacturer Narrative

(b)(4).The device history record of batch number 74m2101790 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.

Manufacturer Narrative

(b)(4).The ats connector p/n 152753 with a section of tubing was received for analysis.During the visual inspection a damage was observed on o-ring p/n 154589.A dimensional inspection was not performed as part of this complaint investigation.The ats connector was connected to a source of air (tfm-0060 nlc09684) and it was immerse in water, then it was observed bubbling at red and blue connector interface.Such bubbling confirms the leak in ats connector.The device history record of batch number 74m2101790 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 & inspected according to our specifications.A capa 252 was opened in order to address "trend in complaints due to pleur evac leaking" customer complaint is confirmed, there is a leak on ats connector.A capa 252 was opened in order to address "trend in complaints due to pleur evac leaking".

Event Description

It was reported that leakage was found between the red and blue fast click connector while using in patient.There was no reported injury.

• Brand Name: PE ADULT-PED 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15759012
• MDR Text Key: 307506638
• Report Number: 3004365956-2022-00089
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631279
• UDI-Public: 34026704631279
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028446
• Device Catalogue Number: A-7000-08LF
• Device Lot Number: 74M2101790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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; NONE REPORTED