MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-05042
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The report states that "the head of nursing reports that when inserting the introducer and passing the guide, it does not reveal a hole in the device, for this reason the device is not used".No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.
Additional Manufacturer Narrative
Qn# (b)(4).Upon further review it was determined that this was not a reportable event, thus, the initial mdr submitted on 29 march 2024 should be retracted.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
The report states that "the head of nursing reports that when inserting the introducer and passing the guide, it does not reveal a hole in the device, for this reason the device is not used".No patient harm or injury.The patient status is reported as "fine".At the time of this report, the customer has not returned our requests for additional information.

• Brand Name: PICC SET: 2-LUMEN 4 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19005810
• Report Number: 9680794-2024-00278
• Device Sequence Number: 9420488
• Product Code: LJS
• UDI-Device Identifier: 00801902095367
• UDI-Public: 00801902095367
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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 Catalogue Number: PR-05042
• Device Lot Number: 14F23A0049
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Male