MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC SET 2-L: 5.5 FR X 50 CM; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-45052-HP
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Udi number: (b)(4).
Event or Problem Description
It was reported "i request to review the lot of the picc catheter insertion supplies because today we have placed 3 and the 3 dilator and the guide have been bent, which makes it difficult to perform the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include:9680794-2024-00598, 9680794-2024-00597, 9680794-2024-00596, 9680794-2024-00650, 9680794-2024-00649, 9680794-2024-00648.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.The customer report of a damaged dilator was not confirmed through visual analysis of the customer provided photo.The dilator was not visible within the provided photo.Full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, 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 "i request to review the lot of the picc catheter insertion supplies because today we have placed 3 and the 3 dilator and the guide have been bent, which makes it difficult to perform the procedure." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include:9680794-2024-00598, 9680794-2024-00597, 9680794-2024-00596, 9680794-2024-00650, 9680794-2024-00649, 9680794-2024-00648.

• Brand Name: ARROW AM PICC SET 2-L: 5.5 FR X 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19583743
• Report Number: 9680794-2024-00648
• Device Sequence Number: 11636242
• Product Code: LJS
• UDI-Device Identifier: 10801902095722
• UDI-Public: (01)10801902095722(11)230518(17)240830(10)14F23E0004(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2024

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
• Device Expiration Date: 08/30/2024
• Device Catalogue Number: PR-45052-HP
• Device Lot Number: 14F23E0004
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2023
• 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