MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7 FR X 30 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN055193
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: device was placed on (b)(6) 2020.On (b)(6) 2021, "the luer-lock connection (white head) had fall off" when clamping the line after flushing.The next day a leak was found "between the brown head and catheter" (captured in 3006425876-2021-00049) and the device was removed and replaced.No patient injury or complication reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The complaint is reported as: device was placed on (b)(6) 2020.On (b)(6) 2021, "the luer-lock connection (white head) had fall off" when clamping the line after flushing.The next day a leak was found "between the brown head and catheter" (captured in 3006425876-2021-00049) and the device was removed and replaced.No patient injury or complication reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing a cvc extension line.Visual analysis revealed that one of the luer hubs had separated from the extension line.The separated luer hub was not pictured.A probable cause of the extension line/luer hub separation cannot be determined without the actual sample to evaluate.A device history record review was performed and no relevant findings were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report of a separated extension line/luer hub was confirmed through examination of the customer supplied photo.The image showed the luer hub was missing from the extension line; however, the actual complaint sample was not returned for evaluation.A device history record review was performed, and no relevant findings were identified.The probable cause of the extension line luer hub separation could not be determined based upon the information provided and without the actual sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 30 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11222294
• Report Number: 3006425876-2021-00050
• Device Sequence Number: 4037071
• Product Code: FOZ
• UDI-Device Identifier: 10801902146554
• UDI-Public: 10801902146554
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• 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): 01/07/2021

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: No Information
• Device Expiration Date: 05/11/2022
• Device Model Number: IPN055193
• Device Catalogue Number: CS-24703-E
• Device Lot Number: 71F20F0483
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 02/22/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 02/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.