MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA KIT: 5.5 FR X 55 CM; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN056682
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Clinician placed catheter through passage of sheath.He noticed a "grabbing" at the sheath, but still able to pass through until 1/4 advanced length of catheter.He states he met resistance and unable to advance catheter through sheath.At this point he attempted to retract catheter while holding sheath in place.He reported significant difficulty in pulling catheter back out and stated "it was stuck".Procedure aborted.No patient harm reported.No medical intervention required.The patient's condition was reported to be fine.
Additional Manufacturer Narrative
(b)(4).
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
Clinician placed catheter through passage of sheath.He noticed a "grabbing" at the sheath, but still able to pass through until 1/4 advanced length of catheter.He states he met resistance and unable to advance catheter through sheath.At this point he attempted to retract catheter while holding sheath in place.He reported significant difficulty in pulling catheter back out and stated "it was stuck".Procedure aborted.No patient harm reported.No medical intervention required.The patient's condition was reported to be fine.

• Brand Name: ARROW AGBA PICC/DELTA KIT: 5.5 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: 14047432
• Report Number: 9680794-2022-00212
• Device Sequence Number: 11955901
• Product Code: LJS
• UDI-Device Identifier: 10801902167719
• UDI-Public: 10801902167719
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2022

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
• Device Expiration Date: 06/30/2023
• Device Model Number: IPN056682
• Device Catalogue Number: ASK-45552-MHBV
• Device Lot Number: 13F21L0300
• 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: 03/16/2022
• Supplement Date Received by Manufacturer: 04/30/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2021
• 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
• Patient Sex: Unknown