MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number	ASK-45541-MHBV
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "extension line cracked (lengthwise) about 1 day following insertion.Noted that it was a difficult insertion that took about 2 hours".The picc line was pulled and replaced with another line.The patient had no harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, 1-lumen catheter for analysis.Signs of use were observed inside the extension line.Visual analysis revealed a slit in the distal extension line.The slit was localized to a single area and did not extend along the length of the extrusion , most likely the result of the extension line contacting sharps.The appearance of the damage is consistent with damage resulting from contact with a sharp instrument (i.E.Scalpel, scissors, etc.).Microscopic examination confirmed the damage.No other defects or anomalies were observed.The slit was measured 31mm from the juncture hub.The distal extension line measured 1 15/16" or 1.9375", which is within the specification limits of 1.924" - 1.986" per extension line product drawing.The distal extension line outer diameter measured 0.0935", which is within the specification limits of 0.093" - 0.097" per the distal extension line extrusion product drawing.The distal extension line inner diameter measured 0.056", which is within the specification limits of 0.055" - 0.059" per the distal extension line extrusion product drawing.A lab inventory syringe filled water was attached to the extension line and flushed.When flushing the distal line, water was observed leaking from the crack.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen".A manual tug test confirmed that the extension line was secure within its respective hubs.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of a cracked extension line was confirmed through complaint investigation.Visual and dimensional analysis revealed that the extension line had a slit measured 31mm from the juncture hub.The appearance of the damage is consistent with damage resulting from contact with a sharp instrument (i.E.Scalpel, scissors , etc.).Despite the damage, the catheter met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received , unintentional use error from the extension line making contact with sharps likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "extension line cracked (lengthwise) about 1 day following insertion.Noted that it was a difficult insertion that took about 2 hours".The picc line was pulled and replaced with another line.The patient had no harm or injury.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 1L 4.5 FR X 55 CM
• 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: 21334346
• Report Number: 9680794-2025-00120
• Device Sequence Number: 15561400
• Product Code: LJS
• UDI-Device Identifier: 10801902167696
• UDI-Public: (01)10801902167696(11)240828(17)251108(10)33F24F0791(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 11/08/2025
• Device Catalogue Number: ASK-45541-MHBV
• Device Lot Number: 33F24F0791
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/14/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2024
• 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 Sex: Unknown