MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI CVC KIT: 4L 8.5FR X 16CM AGB+; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-42854-PMM
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during use on a patient, "tpn was coming out of the insertion site".No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that during use on a patient, "tpn was coming out of the insertion site".No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer report of an extension line leak could not be confirmed through investigation of the returned sample.The customer returned one, 4-lumen cvc catheter for analysis.Signs of use were observed.Visual inspection of the catheter revealed no obvious defects or anomalies were observed.Each of the four lumens passed functional leak testing performed per iso and no evidence of leaking, backflow, or interlumen crossover was observed with any of the lumens.A device history record review was performed, and no relevant findings were identified.Based on the customer report and the testing of the sample received, no problem was found with the returned device.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: PI CVC KIT: 4L 8.5FR X 16CM AGB+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19353201
• Report Number: 9680794-2024-00482
• Device Sequence Number: 7466562
• Product Code: FOZ
• UDI-Device Identifier: 10801902131468
• UDI-Public: 10801902131468
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2024

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 Catalogue Number: ASK-42854-PMM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown