MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CVC SET: 4-LUMEN 8.5 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN030195
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "accidental removal of the central venous catheter due to defective equipment.The attachment points of the catheter are intact and properly attached to the skin.(fragile plastic of the fins does not guarantee the safety of the catheter attachment".The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer report of a migrated catheter was confirmed through complaint investigation of the returned sample.The customer returned one 4-l cvc for evaluation.Signs-of-use were observed on the catheter body and within the extension lines.Visual inspection of the catheter revealed the juncture hub suture wings were torn.Microscopic examination confirmed the damage.The observed tears in the suture wings did not occur at the moulding seam.The suture wing tears appeared rough and jagged and appear consistent with undue force being applied to the catheter while inserted and secured.The instructions-for-use (ifu) provided with the kit warns the user, "use a catheter stabilization device, catheter clamp and fastener, staples or sutures (where provided).Use catheter hub as primary securement site.Use catheter clamp and fastener as a secondary securement site as necessary.Precaution: minimize catheter manipulation throughout procedure to maintain proper catheter tip position." a device history record review was performed based on a potential lot number from sales history, and no relevant findings were identified.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported "accidental removal of the central venous catheter due to defective equipment.The attachment points of the catheter are intact and properly attached to the skin.(fragile plastic of the fins does not guarantee the safety of the catheter attachment".The patient's current condition is reported as "fine".

• Brand Name: CVC SET: 4-LUMEN 8.5 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18710304
• Report Number: 3006425876-2024-00189
• Device Sequence Number: 8192161
• Product Code: FOZ
• UDI-Device Identifier: 00801902102423
• UDI-Public: 00801902102423
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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 Model Number: IPN030195
• Device Catalogue Number: CS-45854-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2024
• Supplement Date Received by Manufacturer: 03/19/2024
• Initial Report FDA Received Date: 02/15/2024
• Supplement Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown