MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC KIT: 1L 4.5FR 55CM AGBA TIPTRACK; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CDA-45541-TTS
Medical Device Problem Codes	Malposition of Device (2616); Migration (4003)
Health Effect - Clinical Codes	Fever (1858); Foreign Body In Patient (2687)
Date of Event	11/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: " patient had a picc line for bloods and iv antibiotics, and it was noticed that the picc lumen was not in place only the dressing, patient had a spike of temperature around the time and as part of septic screen chest x-ray was performed and part of the humerus was x-rayed, which revealed picc lumen and the clip inside patient skin.Patient was then taken to theatre to have it removed under local anesthetic".
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 that: " patient had a picc line for bloods and iv antibiotics, and it was noticed that the picc lumen was not in place only the dressing, patient had a spike of temperature around the time and as part of septic screen chest x-ray was performed and part of the humerus was x-rayed, which revealed picc lumen and the clip inside patient skin.Patient was then taken to theatre to have it removed under local anesthetic".

• Brand Name: ARROW PI PICC KIT: 1L 4.5FR 55CM AGBA TIPTRACK
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19273514
• Report Number: 9680794-2024-00389
• Device Sequence Number: 7439685
• Product Code: LJS
• UDI-Device Identifier: 40801902125536
• UDI-Public: 40801902125536
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: CDA-45541-TTS
• Device Lot Number: UNKNOWN
• 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: 04/10/2024
• Supplement Date Received by Manufacturer: 05/30/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 05/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown