MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC SET 1-L: 4.5 FR X 50 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	PR-45041-HP
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: " a report is received from oncology indicating that the clamp split and detached, leaving the patient with picc inserted, but without a safety key.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a slide clamp coming off was able to be confirmed by the photo.The photo revealed the distal extension line with the catheter slide clamp not present on the line.Kinking of the extension line was observed, which is likely where the slide clamp was placed originally.However, without the sample returned for analysis, a complete visual inspection could not be performed.A device history record review was performed, and a finding was identified; however without the sample returned for analysis, it cannot be determined if the finding is relevant to the reported event.The instructions for use (ifu) provided with this kit informs the user, "clinicians should be aware that slide clamps may be inadvertently removed." the customer report of a slide clamp coming off was confirmed by visual inspection of the customer supplied photo.The image shows a catheter in use with the extension line missing the slide clamp (the clamp is not pictured).However, full complaint verification testing could not be performed as no sample was returned for analysis.The instructions for use (ifu) provided with this kit informs the user, "clinicians should be aware that slide clamps may be inadvertently removed." 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 that: " a report is received from oncology indicating that the clamp split and detached, leaving the patient with picc inserted, but without a safety key.".

• Brand Name: ARROW AM PICC SET 1-L: 4.5 FR X 50 CM
• 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: 20332820
• Report Number: 9680794-2024-00951
• Device Sequence Number: 8004165
• Product Code: LJS
• UDI-Device Identifier: 10801902095715
• UDI-Public: (01)10801902095715(11)230517(17)250425(10)14F23E0115(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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2024

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: 04/25/2025
• Device Catalogue Number: PR-45041-HP
• Device Lot Number: 14F23E0115
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2023
• 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: NOT REPORTED.; NOT REPORTED.
• Patient Age: 72 YR
• Patient Sex: Male