MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC 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	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Picc was placed on (b)(6) 2022 in right basilic with 0 cm out.On (b)(6) 2022 the picc was leaking.The nurse noticed the dressing getting wet.The dressing was removed and saw leak.The nurse notified the vascular access team and the picc was replaced.No patient harm.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-l picc for analysis.The catheter appeared intentionally severed.Visual inspection of the catheter revealed a small hole on the catheter body, near the juncture hub.The appearance of the damage is consistent with contact with a sharp instrument (i.E.Scalpel, scissors, etc.) during suturing of the catheter.The total length of the catheter body measured 2 1/8" which is not within the specifications of 22 3/4"-23" per product drawing.This indicates that at least 20 5/8" were cut and not returned for analysis.Functional inspection was performed on the returned catheter to recreate the product's intended use.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".The catheter body leaked out of the small hole near the juncture hub.A manual tug test confirmed the extension lines were fully secured within their respective hubs.A device history record review was performed, and the following potentially relevant findings were identified: for material mc-45552-002c, a non-conformance was initiated for 13c20f1602 in regards to swg test fail.For material c-15802-037a, a non-conformance was initiated for 13c20a1040 in regards to picc is leaking at hub and a non-conformance was initiated for 13c20a1040 in regards to extension line leak during use.For material c-15802-032a, a non-conformance was initiated for 13c21f2564, 13c21f2563, 13c21f1375 and 13c21f2562 in regards to extension line/luer hub superation.The non-conformances identified are not relevant to the damage observed with the returned catheter.The instructions for use (ifu) provided with this kit 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 customer report of a catheter body leak was confirmed by complaint investigation of the returned sample.During functional leak testing, a leak was found from the catheter body.Visual inspection revealed a small hole in the catheter body near the juncture hub, which is consistent with damage caused by unintentional contact with sharps.Based on the customer report that the damage was observed during use and the sample received, unintentional use error is the probable root cause for this complaint.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
Picc was placed on (b)(6) 2022 in right basilic with 0 cm out.On (b)(6) 2022 the picc was leaking.The nurse noticed the dressing getting wet.The dressing was removed and saw leak.The nurse notified the vascular access team and the picc was replaced.No patient harm.The patient's condition is reported as fine.

• 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 LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14311988
• Report Number: 9680794-2022-00286
• Device Sequence Number: 12080755
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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: 02/28/2023
• Device Model Number: IPN037301
• Device Catalogue Number: CDC-45552-VPS2
• Device Lot Number: 13S20L0104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/27/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.; NOT REPORTED.
• Patient Sex: Unknown