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	04/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#:(b)(4).
Event or Problem Description
The complaint is reported as: "the extension line was severed very close to the injection hub and fell off in her hand while the nurse was applying the slide clamp.The slide clamp was used to occlude the extension, the line was removed and then replaced." no patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#: (b)(4).The customer did not return a complaint sample; however, they supplied a photo showing the distal luer hub completely separated from the distal extension line.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 ifu also states, "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 that the extension line separated from the luer hub was confirmed through examination of the customer supplied photo.The image showed the distal luer hub was completely separated from the distal extension line; however, the actual complaint sample was not returned for evaluation.The device history record was reviewed 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.
Event or Problem Description
The complaint is reported as: "the extension line was severed very close to the injection hub and fell off in her hand while the nurse was applying the slide clamp.The slide clamp was used to occlude the extension, the line was removed and then replaced." no patient harm 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: 11776972
• Report Number: 9680794-2021-00196
• Device Sequence Number: 3946308
• Product Code: DYB
• UDI-Device Identifier: 30801902120756
• UDI-Public: 30801902120756
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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): 04/15/2021

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: 03/31/2022
• Device Model Number: IPN037300
• Device Catalogue Number: CDC-45052-VPS2
• Device Lot Number: 13F20M0581
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1