MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR; CATHETER,INTRAVASCULAR,THERAPE

Model Number IPN920209

Device Problems Difficult to Advance (2920); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported picc line would not advance into the peel-away sheath.The distal end of the catheter advanced but they were unable to advance the entire picc.They were finally able to "force" the catheter through the sheath and complete the procedure.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (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 with one relevant finding identified.For material cdc-45552-cat2 and lot 13c21e1118, a non-conformance was initiated in regards to a stylet tight in picc catheter.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.Do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage." 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 Description

Customer reported picc line would not advance into the peel-away sheath.The distal end of the catheter advanced but they were unable to advance the entire picc.They were finally able to "force" the catheter through the sheath and complete the procedure.No patient harm reported.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR
• Type of Device: 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: 13578139
• MDR Text Key: 286076223
• Report Number: 9680794-2022-00112
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 10801902192568
• UDI-Public: 10801902192568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153487
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN920209
• Device Catalogue Number: ASK-45552-CRMC
• Device Lot Number: 13F21L0426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1