MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 4L 8.5 FR X 20 CM AGB+; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-45854-PSHS1
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "on 5/29 the nurse was doing her am line assessment and noticed the gown/shoulder area of the patient, same side as catheter was placed, was wet.The nurse then noticed leaking was coming from the microclave neutral displacement connectors, that come in the kit, & were attached to the lumen hubs.Because these connectors appeared to be cracked and leaking, not sure if all (4) were affected, the rn changed all 4 from single sterile inventory, and the issue was resolved." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2024-00636, 9680794-2024-00607, and 9680794-2024-00661.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on 5/29 the nurse was doing her am line assessment and noticed the gown/shoulder area of the patient, same side as catheter was placed, was wet.The nurse then noticed leaking was coming from the microclave neutral displacement connectors, that come in the kit & were attached to the lumen hubs.Because these connectors appeared to be cracked and leaking, not sure if all (4) were affected, the rn changed all 4 from single sterile inventory, and the issue was resolved." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 9680794-2024-00637, 9680794-2024-00636, 9680794-2024-00607, and 9680794-2024-00661.

• Brand Name: ARROW PI CVC KIT: 4L 8.5 FR X 20 CM AGB+
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19605728
• Report Number: 9680794-2024-00637
• Device Sequence Number: 6359584
• Product Code: FOZ
• UDI-Device Identifier: 10801902156225
• UDI-Public: (01)10801902156225(11)230727(17)240930(10)33F23G0319(21)
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2024

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: 09/30/2024
• Device Catalogue Number: ASK-45854-PSHS1
• Device Lot Number: 33F23G0319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/19/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown