MAUDE Adverse Event Report: TELEFLEX MEDICAL PE DRY/WET CONT REINFUSION LF 6/CS; APPARATUS, AUTOTRANSFUSION

Model Number	IPN028454
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).The device history record of batch number 74h2200822 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
Reported issue: leak would resolve when using pressure to hold the red clamp and tube together tightly.Waterproof tape attempted and did not help.Changed drainage systems which fixed the issue.

• Brand Name: PE DRY/WET CONT REINFUSION LF 6/CS
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• 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: 16624137
• Report Number: 3004365956-2023-00022
• Device Sequence Number: 14989737
• Product Code: CAC
• UDI-Device Identifier: 14026704631350
• UDI-Public: 14026704631350
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140197
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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: 08/12/2025
• Device Model Number: IPN028454
• Device Catalogue Number: A-9250LF
• Device Lot Number: 74H2200822
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 03/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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: REPORTED ISSUE
• Patient Sex: Unknown