MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037308
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
The complaint is reported as: hub separation from extension line.Picc inserted on (b)(6) 2021.No patient injury or complication reported.The patient's condition is reported as fine.It was reported there was a delay in therapy without harm to the patient.
Event or Problem Description
The complaint is reported as: hub separation from extension line.Picc inserted on (b)(6) 2021.No patient injury or complication reported.The patient's condition is reported as fine.It was reported there was a delay in therapy without harm to the patient.
Additional Manufacturer Narrative
(b)(4).The customer did not return a complaint sample; however, they supplied a photo showing a picc catheter while inside the patient.Visual analysis revealed that the distal luer hub has separated from the extension line; however, it cannot be confirmed if a portion of the extension line is still within the luer hub as the sample was not returned for evaluation.A probable cause of the extension line/luer hub separation cannot be determined from the photos and without the sample to evaluate.A device history record review was performed with no evidence to suggest a manufacturing related cause.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 examination of the customer supplied photo.The image showed that the distal luer hub had separated from the extension line; however , the actual complaint sample was not returned for evaluation.A device history record review was performed with no evidence to suggest a manufacturing related cause.The probable cause of the extension line luer hub separation could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 40 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12276867
• Report Number: 9680794-2021-00393
• Device Sequence Number: 17309316
• Product Code: LJS
• UDI-Device Identifier: 50801902120705
• UDI-Public: 50801902120705
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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): 07/21/2021

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: 01/31/2022
• Device Model Number: IPN037308
• Device Catalogue Number: CDC-44052-VPS2
• Device Lot Number: 13F20K0365
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/21/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/04/2021
• Supplement Report FDA Received Date: 09/07/2021
• 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