MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM; CATHETER INTRAVSCULAR THERAPEU

Model Number	IPN037301
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Customer reported leaking/hole where extension line meets the hub on the picc line.The device was replaced.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-l picc for evaluation.Visual inspection of the photos revealed there was a hole in the distal extension line adjacent to the luer hub.This damaged is consistent with the molding defect seen on picc extension lines.The catheter body also appeared to be intentionally cut.The total length of the catheter body measured 404 mm, or 40.4 cm, which is not within specifications of 54.60-55.90 cm per catheter product drawing.This indicates at least 14.2 cm of the catheter body was cut and not returned.The outer diameter of the distal extension line measured 0.09505", which is within specifications of 0.093-0.097" per distal extrusion graphic.The inner diameter of the distal extension line measured 0.056", which is within specifications of 0.055-0.059" per distal extrusion graphic.This indicates that the wall thickness measured as expected.Both extension lines were flushed according to the ifu which 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." water leaked out of the hole in distal line.The proximal line flushed as expected.A manual tug test confirmed both luer hubs were secure to their extension lines.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple, and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the complaint of an extension line leak was confirmed through a complaint investigation on the returned sample.A hole was found in the distal extension line adjacent to the luer hub.The returned sample passed all relevant dimensional inspections.A device history record review was performed, and no relevant findings were identified.The type of damage observed is consistent with a manufacturing issue in the picc lines.A non-conformance request has been initiated to further investigate this issue.
Event or Problem Description
Customer reported leaking/hole where extension line meets the hub on the picc line.The device was replaced.No patient harm reported.

• Brand Name: ARROW AGBA PICC/DELTA FG: 2-L 5.5 FR X 55 CM
• Common Device Name: CATHETER INTRAVSCULAR THERAPEU
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11904377
• Report Number: 9680794-2021-00257
• Device Sequence Number: 17248492
• Product Code: LJS
• UDI-Device Identifier: 30801902120794
• UDI-Public: 30801902120794
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153487
• 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): 05/13/2021

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: 05/31/2022
• Device Model Number: IPN037301
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 13F21A0668
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 05/13/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 07/02/2021
• 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.