MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN056359
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Patient had a triple lumen picc and one of the hubs popped off while the unit nurse was caring for the patient.The user clamped the broken lumen, placed a new picc, and then removed the initial catheter.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-lumen picc for evaluation.The catheter contained significant signs of use in the form of biological material.Visual examination revealed the distal luer was separated from the lumen.Remnants of the extrusion remained within the luer.The distal lumen appeared significantly stretched, indicating undue force likely caused the damage.The distal lumen also contained a compressive marking from the slide clamp.The total length of the catheter body measured to be 17.56" which indicates at least 5.5" were trimmed and not returned per product drawing.The inner diameter of the distal lumen measured to be 0.058" which is within specifications of 0.055-0.059" per product drawing.The outer diameter of the distal lumen measured to be 0.096" which is within specifications of 0.093-0.097" per product drawing.A manual tug test confirmed the distal and medial luers were fully secured to their respective lumens.A device history record review was performed with no relevant findings.The ifu provided with this kit warns the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested." the customer report of a separated luer was confirmed by complaint investigation of the returned sample.The distal luer was detached and the lumen contained significant signs of stretching, indicating undue force caused or contributed to the damage.The sample passed all relevant dimensional inspection and a device history record review was performed with no relevant findings.Based on the condition of the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
Patient had a triple lumen picc and one of the hubs popped off while the unit nurse was caring for the patient.The user clamped the broken lumen, placed a new picc, and then removed the initial catheter.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12356193
• Report Number: 9680794-2021-00423
• Device Sequence Number: 14557358
• Product Code: LJS
• UDI-Device Identifier: 10801902161793
• UDI-Public: 10801902161793
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2021

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: 03/31/2022
• Device Model Number: IPN056359
• Device Catalogue Number: ASK-45563-UWH
• Device Lot Number: 13F20K0577
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Initial Date Received by Manufacturer: 08/09/2021
• Supplement Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 08/23/2021
• Supplement Report FDA Received Date: 09/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED; NOT REPORTED