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

Model Number	IPN028446
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3004365956-2022-00089
• Device Sequence Number: 15515406
• Product Code: KDQ
• UDI-Device Identifier: 34026704631279
• UDI-Public: 34026704631279
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/19/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 11/09/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown