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  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

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.

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

Qn#(b)(4).No sample was returned for analysis.Customer complaint is confirmed, the unit had a leak on ats connector.However, it can't be observe the exactly place where the leak cam from.Product sample is necessary to perform a proper investigation.Nevertheless, a capa 252 was opened in order to address "trend in complaints due to pleur evac leaking".

• 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: 15759092
• MDR Text Key: 307082338
• Report Number: 3004365956-2022-00096
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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