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

Model Number	IPN028446
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history record of batch number 74m2101787 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.
Event or Problem Description
Air heard hissing from pleurevac.Air leak noted.Entire pleurevac changed and then no issue.No visible crack but air leak from red/blue connector.The same issue has happened with all of these chest drains.2 of the 6 were used in a clinical setting.The remaining drains were tested outside of using on a patient and the customer found similar issues on them.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 14116007
• Report Number: 3004365956-2022-00031
• Device Sequence Number: 5795855
• Product Code: KDQ
• UDI-Device Identifier: 34026704631279
• UDI-Public: 34026704631279
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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: 12/16/2024
• Device Model Number: IPN028446
• Device Catalogue Number: A-7000-08LF
• Device Lot Number: 74M2101787
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown