MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS; INTRODUCER, CATHETER

Model Number	IPN037307
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
Customer reported the hub snapped off of the picc line.The line had been placed and was in use for 3 days prior to the issue.The picc line was replaced in the opposite arm.It was reported there was no patient injury or consequence as a result of this issue.The nurse noted white medication left in the lumen, either diprovan or propfol, when replacing the line.The patient was intubated and in icu.The patient's condition was reported as critical at the time of this report.
Additional Manufacturer Narrative
Qn#: (b)(4).The customer did not return the actual sample; however, they provided one photo for evaluation.Visual examination of the photo confirmed that the proximal luer hub was separated from the lumen.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit warns 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 customer report of a luer hub separation was confirmed by evaluation of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Customer reported the hub snapped off of the picc line.The line had been placed and was in use for 3 days prior to the issue.The picc line was replaced in the opposite arm.It was reported there was no patient injury or consequence as a result of this issue.The nurse noted white medication left in the lumen, either diprovan or "propofol", when replacing the line.The patient was intubated and in icu.The patient's condition was reported as critical at the time of this report.

• Brand Name: ARROW PI AGBA PICC KIT: 3-L 6 FR X 55 CM W/VPS
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11823536
• Report Number: 9680794-2021-00217
• Device Sequence Number: 11739663
• Product Code: DYB
• UDI-Device Identifier: 50801902120811
• UDI-Public: 50801902120811
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2021

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: 01/31/2022
• Device Model Number: IPN037307
• Device Catalogue Number: CDC-45563-VPS2
• Device Lot Number: 13F20J0958
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/13/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR