MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM; INTRODUCER, CATHETER

Model Number	IPN037300
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the "port fell off" from the catheter.It was discovered when the nurse went into the room.The catheter was replaced with another picc.No patient harm or injury reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one, 2-l picc for analysis.Signs-of-use in the form of biological material were observed inside the extension lines.Visual analysis revealed that the distal luer hub had become separated from its extension line.The luer hub was not returned for analysis.Microscopic examination revealed that the separation at the extension line was rough and jagged.The catheter body was also noted to be intentionally cut and the separated portion was not returned.The catheter body length from the juncture hub to the point of separation measured 18" which is not within the specification limits of 19.5-20" per the catheter graphic.This indicates that at least 1.5" of the catheter body were separated and not returned for analysis.The distal extension line outer diameter measured 0.09375" which is within the specification limits of 0.093-0.097" per the distal extension line extrusion graphic.The distal extension line inner diameter measured 0.056" which is within the specification limits of 0.055-0.059" per the distal extension line extrusion graphic.This indicates that the distal extension line had a wall thickness within specification.The catheter was functionally testing per the instructions for use (ifu).The ifu provided with this kit states, "attach pre-filled saline syringe, if provided, or other syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place.Flush remaining lumen(s) with sterile saline.Clamp or attach injection site cap(s) to extension line(s) to contain saline within lumen." a lab inventory syringe filled with water was attached to the proximal extension line and flushed.The proximal line flushed as expected.A manual tug test confirmed that the proximal luer hub was secure to its extension line.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.Excessive force can cause catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested.Do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce the risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of a luer hub/extension line separation was confirmed through complaint investigation.Visual analysis revealed that the distal luer hub had become separated from its extension line.The catheter met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on the customer report and the sample received, the root cause could not be determined without the separated luer hub.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the "port fell off" from the catheter.It was discovered when the nurse went into the room.The catheter was replaced with another picc.No patient harm or injury reported.The patient's condition is reported as fine.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 50 CM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12478824
• Report Number: 9680794-2021-00457
• Device Sequence Number: 3821868
• Product Code: DYB
• UDI-Device Identifier: 30801902120756
• UDI-Public: 30801902120756
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 08/27/2021

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: 10/31/2022
• Device Model Number: IPN037300
• Device Catalogue Number: CDC-45052-VPS2
• Device Lot Number: 13F21G0626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: 08/27/2021
• Supplement Date Received by Manufacturer: 10/13/2021
• Initial Report FDA Received Date: 09/15/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.