MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Model Number IPN038304

Device Problem Migration or Expulsion of Device (1395)

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

Event Date 01/11/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

The complaint is reported as: the catheter was inserted into a 3-month old patient's right groin on (b)(6) 2021 and secured by suture through the securement wings.On (b)(6) 2021 it was found that one of the securement wings was broken and the catheter "slipped out".No fluids were infusing at the time.No patient harm or complication reported.A new catheter was inserted.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one 2-lumen catheter for evaluation.Visual examination revealed one suture wing on the juncture hub was torn.The separation points were rough and jagged which is consistent with undue force being applied to the line.A device history record review was performed with no relevant findings.The ifu provided with this kit instructs the user, "use triangular juncture hub with side wings as primary suture site.Use catheter clamp and fastener as a secondary suture site as necessary." the customer report of a catheter migration was confirmed by complaint investigation of the returned sample.Based on the sample received and the fact that the incident occurred during use, unintentional user error likely caused or contributed to this event.Teleflex will continue to monitor and trend complaints of this nature.

Event Description

The complaint is reported as: the catheter was inserted into a (b)(6) old patient's right groin on (b)(6) 2021 and secured by suture through the securement wings.On (b)(6) 2021 it was found that one of the securement wings was broken and the catheter "slipped out".No fluids were infusing at the time.No patient harm or complication reported.A new catheter was inserted.The patient's condition is reported as fine.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 11697243
• MDR Text Key: 247795396
• Report Number: 3006425876-2021-00364
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 10801902139044
• UDI-Public: 10801902139044
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/30/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2023
• Device Model Number: IPN038304
• Device Catalogue Number: CS-14402
• Device Lot Number: 71F18K1635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/30/2021
• Initial Date FDA Received: 04/20/2021
• Supplement Dates Manufacturer Received: 05/18/2021
• Supplement Dates FDA Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2018
• 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 Age: 3 MO