MAUDE Adverse Event Report: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"; CATHETER,INTRAVASCULAR,THERAPE

Model Number	IPN038522
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "when my nurse flushed the line, the cap broke off the lumen".No patient injury or consequence reported.Device was replaced.Unknown patient condition at time of report.
Additional Manufacturer Narrative
Qn#(b)(4).The customer did not return a complaint sample; however, they supplied four photos showing a defective cvc catheter.Visual analysis revealed that the proximal luer hub was separated from the proximal extension line.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested." the report of an extension line/luer hub separation was confirmed through analysis of the customer supplied photos.The images showed that the proximal luer hub had separated from the proximal extension line; however, the actual complaint sample was not returned for evaluation.A device history record review could not be performed as no lot number was provided by the customer and no sales history is available.The probable cause of the extension line/luer hub separation cannot be determined based upon the information provided and without the actual complaint sample returned for analysis.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "when my nurse flushed the line, the cap broke off the lumen".No patient injury or consequence reported.Device was replaced.Unknown patient condition at time of report.

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 6"
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPE
• MDR Report Key: 12177850
• Report Number: 9680794-2021-00332
• Device Sequence Number: 19240378
• Product Code: FOZ
• UDI-Device Identifier: 10801902141030
• UDI-Public: 10801902141030
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K071538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2021

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 Model Number: IPN038522
• Device Catalogue Number: ASK-42703-PCCH2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 08/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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.