MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC KIT: 2-L 5.5 FR X 55 CM VPS; INTRODUCER, CATHETER

Model Number IPN911883

Device Problem Material Puncture/Hole (1504)

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

Event Date 12/24/2021

Event Type  malfunction  

Event Description

A patient was sent home with a picc.Once at home, it was noted that there was a hole in the tubing portion of the hub.The patient is very unhappy as they had to be readmitted to the hospital to resume therapy and receive another picc.The medication drip had to be delayed due to this.The patient was reported to be fine.No injury or complication reported.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one 2-lumen picc catheter for evaluation.Evidence of use was observed on the returned device and the catheter body had been intentionally truncated.Visual inspection of the catheter revealed there was a large cut in the center of the distal extension line.The cut was uniform and horizontal across the extension line body.The appearance of the damage is consistent with damage resulting from contact with a sharp instrument (i.E.Scalpel, scissors, etc).Adhesive residue was observed on the extension lines indicating a dressing had previously been applied.A non-teleflex clamp was attached to the proximal extension line indicating the original slide clamp had been removed.The slide clamp on the distal extension line contained no burrs or sharp edges.No other defects or anomalies were observed with the returned device.The damage to the extension line was located 0.6885" from the base of the distal luer hub.The outer diameter of the distal extension line measured 0.095" which is within specifications of 0.093"-0.097" per distal extrusion graphic.The inner diameter of the proximal extension line measured 0.057" which is within specifications of 0.055"-0.059" per distal extrusion graphic.This indicates that the wall thickness measured within specifications.The returned sample was functionally tested in accordance with the instructions-for-use (ifu) provided with this kit.The ifu instructs the user, "flush each lumen with sterile saline solution, to establish patency and prime lumen(s)." when the distal line was flushed, water leaked from the cut in the extension line.No leaks were observed when the proximal lumen was flushed.A manual tug test confirmed that both extension lines were secure within their respective luer hubs.A device history record review was performed, and no relevant findings were identified.For material mc-45552-003c, shop order, qa inspection, and non-conformance were reviewed and a non-conformance for 13c21g0960 was identified in regards to a missing component.Missing components are unrelated to the failure mode reported by the customer, therefore, this was deemed to be not relevant to the complaint issue.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the ifu also warns the user "do not use scissors to remove dressing to reduce the risk of cutting the catheter".The customer report of an extension line leak was confirmed by functional and visual inspection of the returned sample.The distal extension line contained a large cut at the center of the body.The appearance of the damage was consistent with contact with a sharp instrument (i.E.Scalpel, scissors, etc).The catheter passed all relevant dimensional testing with no evidence to suggest a manufacturing related issue.Based on the customer report that the defect was identified during use and the appearance of the damage observed, unintentional use error (contact with sharps), likely caused or contributed to this event.Teleflex will continue to monitor and trend reports of this nature.

Event Description

A patient was sent home with a picc.Once at home, it was noted that there was a hole in the tubing portion of the hub.The patient is very unhappy as they had to be readmitted to the hospital to resume therapy and receive another picc.The medication drip had to be delayed due to this.The patient was reported to be fine.No injury or complication reported.

• Brand Name: ARROW PICC KIT: 2-L 5.5 FR X 55 CM VPS
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 13294271
• MDR Text Key: 284913597
• Report Number: 9680794-2022-00067
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10801902135008
• UDI-Public: 10801902135008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112896
• 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: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 12/31/2022
• Device Model Number: IPN911883
• Device Catalogue Number: ASK-45552-VFH
• Device Lot Number: 13F21H0145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2021
• 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
• Treatment: NOT REPORTED; NOT REPORTED
• Patient Outcome(s): Hospitalization