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

Model Number IPN920208

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 05/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Picc was tight in the peelaway sheath, clinician had to remove the arrow 4.5fr sheath and replace it with a 5fr peelaway to advance the picc.Clinician indicated that it initially advanced freely and then she encountered a "tight spot" and could not advance any further.After switching out the peelaway the case was completed without incident.

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 Description

Picc was tight in the peelaway sheath, clinician had to remove the arrow 4.5fr sheath and replace it with a 5fr peelaway to advance the picc.Clinician indicated that it initially advanced freely and then she encountered a "tight spot" and could not advance any further.After switching out the peelaway the case was completed without incident.

• Brand Name: ARROW AGBA VPS PICC KIT: 1-L 4.5 FR X 55 CM
• 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: 14634209
• MDR Text Key: 295493923
• Report Number: 9680794-2022-00366
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 10801902192551
• UDI-Public: 10801902192551
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Model Number: IPN920208
• Device Catalogue Number: ASK-45541-CRMC
• Device Lot Number: 13F22C0334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2022
• 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
• Patient Sex: Female