MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN; CATHETER INTRAVASCULAR THERAPE

Catalog Number	ASK-45703-PGM3
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "the package was supposed to contain a 20cm catheter.The catheter packaged in it was a 16cm catheter.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned the outside packaging of a cvc kit including one catheter for evaluation.No signs of use were observed.Visual analysis revealed the returned catheter is a 16 cm catheter, which is not the intended 20 cm catheter in finished good.No other defects or anomalies were observed.A device history record review was performed, and no relevant findings were identified.The customer report of an incorrect catheter was confirmed through complaint investigation of the returned sample.Visual inspection revealed the returned catheter was 16 cm instead of the intended 20 cm.A device history record review was performed, and no relevant findings were identified.Based on these circumstances, packaging caused or contributed to this event.Non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that: "the package was supposed to contain a 20cm catheter.The catheter packaged in it was a 16cm catheter.The reported defect was detected during use on patient.The patient condition was reported as "fine".No patient injury/consequence or medical intervention reported.".

• Brand Name: MULTI LUMEN PI CVC KIT: 3L 7 FR X 8 IN
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19814295
• Report Number: 9680794-2024-00710
• Device Sequence Number: 8665888
• Product Code: FOZ
• UDI-Device Identifier: 10801902213768
• UDI-Public: (01)10801902213768(11)240105(17)250430(10)33F23L0683(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: ASK-45703-PGM3
• Device Lot Number: 33F23L0683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2024
• Supplement Date Received by Manufacturer: 08/08/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown