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

Model Number IPN028442

Device Problem Gas/Air Leak (2946)

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

Event Date 03/08/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device history record of batch number 74k2200575 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.The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

Reported issue: blood leakage was detected through the red/blue connection of the tubing.The system was changed and the issue was resolved.No injury reported.

Manufacturer Narrative

(b)(4).One unit of catalog number a-6000-08lf (pe adult-ped dry/ wet lf 6/cs) with lot number 74k2200575 was received and sent to the manufacturing site for analysis.The manufacturing site reports: the ats connector was received disconnected, the blue part from the red part.The o-ring was inspected and an irregular surface was observed in some sections.The tubing where the blue connector is was cut.The connectors (blue and red) were connected, and one side was connected to an air source and the other side was clamped.The connector was immersed into water and no bubbling was observed, indicating there was no leakage.The connector was disconnected, connected again and immersed into the water several more times and no leaks were observed.A device history record review was performed and no relevant findings were identified.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Reported issue: blood leakage was detected through the red/blue connection of the tubing.The system was changed and the issue was resolved.No injury reported.

• Brand Name: PE ADULT-PED DRY/ 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194332672
• MDR Report Key: 16622348
• MDR Text Key: 312252866
• Report Number: 3004365956-2023-00024
• Device Sequence Number: 1
• Product Code: KDQ
• UDI-Device Identifier: 34026704631231
• UDI-Public: 34026704631231
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

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
• Device Operator: Health Professional
• Device Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74K2200575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED