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

Model Number IPN028454

Device Problem Leak/Splash (1354)

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

Event Date 02/28/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 312259027
• Report Number: 3004365956-2023-00022
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 14026704631350
• UDI-Public: 14026704631350
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028454
• Device Catalogue Number: A-9250LF
• Device Lot Number: 74H2200822
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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: REPORTED ISSUE