MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Model Number	IPN914872
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports "fractured line".The catheter was inserted on (b)(6) 2022.The issue was detected by the nurse when trying to aspirate line for blood sampling.The catheter was removed and replaced.Upon removal the user visualized saline leaking when flushed on the extension line where it connects to the white hub.No patient harm reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one 2-lumen picc for investigation.Evidence of use was observed and the catheter body appeared to be intentionally cut.Visual inspection revealed the proximal extension line contained a small hole directly adjacent to the luer hub.The remainder of the extension line was secured inside the luer hub.The total length of the catheter body measured to be 18" which is not within the specification of 19 11/16" - 21 11/16" per product drawing.This indicates that at least 1 11/16" of the catheter were cut and not returned for analysis.The outer diameter of the proximal lumen measured to be 0.08560" which is within specifications of 0.084" - 0.088" per product drawing.The inner diameter of the proximal lumen measured to be 0.058" which is within specifications of 0.055" - 0.059" per product drawing.This indicates that the wall thickness measured within specifications.The catheter was functionally tested per the instructions for use (ifu).The ifu provided with this kit instructs the user, "prepare all equipment.For two-lumen catheter, flush proximal lumen with sterile saline solution.Clamp or attach injection cap to proximal lumen pigtail.Flush distal lumen and leave syringe in place." water leaked out of the hole in proximal line.A device history record review was performed, and the following potentially relevant findings were identified: a non-conformance was initiated for material mc-05052-002e, batch 13c21a1745 in regards to an extrusion in the minimum specification.The instructions for use (ifu) provided with this kit warns the user, "precaution: do not suture directly to outside diameter of catheter to minimize the risk of cutting or damaging the catheter or impeding catheter flow.Precaution: to minimize the risk of damage to pigtail(s) from excessive pressure, each clamp must be opened prior to infusing through that lumen." the complaint of an extension line leak was confirmed through a complaint investigation on the returned sample.A hole was found in the proximal extension line adjacent to the luer hub.The returned sample passed all relevant dimensional inspections.The type of damage observed is consistent with a manufacturing issue in the picc lines, therefore, the probable root cause is manufacturing related.A non-conformance has been initiated to further investigate this issue.
Event or Problem Description
Customer reports "fractured line".The catheter was inserted on (b)(6) 2022.The issue was detected by the nurse when trying to aspirate line for blood sampling.The catheter was removed and replaced.Upon removal the user visualized saline leaking when flushed on the extension line where it connects to the white hub.No patient harm reported.

• Brand Name: ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 14196664
• Report Number: 9680794-2022-00248
• Device Sequence Number: 4481733
• Product Code: LJS
• UDI-Device Identifier: 10801902158915
• UDI-Public: 10801902158915
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/01/2022

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: 03/31/2023
• Device Model Number: IPN914872
• Device Catalogue Number: PR-05052
• Device Lot Number: 14F21B0175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/17/2022
• Initial Report FDA Received Date: 04/25/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2021
• 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: VANCOMYCIN AND TAZOCIN.; VANCOMYCIN AND TAZOCIN.
• Patient Sex: Unknown