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	12/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
Customer reported "slide clamps are too tight which can result in torquing of the hub when trying to clamp or unclamp".This causes the hub to "pop off" and the picc needs to be replaced.No patient harm was reported.Patient condition reported as fine.
Event or Problem Description
Customer reported "slide clamps are too tight which can result in torquing of the hub when trying to clamp or unclamp".This causes the hub to "pop off" and the picc needs to be replaced.No patient harm was reported.Patient condition reported as fine.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.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.

• 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: 11228100
• Report Number: 9680794-2021-00025
• Device Sequence Number: 3805769
• 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): 01/08/2021

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: No Information
• Device Model Number: IPN056359
• Device Catalogue Number: ASK-45563-UWH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/18/2021
• 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: NONE REPORTED.; NONE REPORTED.