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

Model Number	IPN038304
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem 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.
Additional 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 or Problem 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
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11697243
• Report Number: 3006425876-2021-00364
• Device Sequence Number: 3499810
• Product Code: DQY
• UDI-Device Identifier: 10801902139044
• UDI-Public: 10801902139044
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 MO