MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PICC SET: 16 GA X 27 1/2IN; CATHETER INTRAVASCULAR THERAPE

Catalog Number	AJ-01671
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the catheter got torn when the user removed the fixing tape during placement.Therefore, it was removed and replaced with a new kit.No harm to the patient occurred." no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
Qn# (b)(4).The customer provided one photo for analysis; the photo shows the picc with the body appearing severed.The customer returned one, single-lumen picc for analysis.Signs of use were observed.Visual analysis revealed the catheter body was severed towards the distal end.Multiple kinks were observed throughout the picc body.Portions of the body appeared stretched and deformed and an adhesive substance was observed on the catheter surface.The customer description suggests the catheter was pulled when the fixing tape was removed.Microscopic examination confirmed the damage and revealed that the points of separation were smooth and uniform with no evidence of stretching observed.The point of separation measured 29.3 cm from the distal tip.The catheter body sections measured 29.3 cm and 54.2 cm, totaling 83.5 cm, which is not within the specification per catheter product drawing.The outer diameter (od) of the catheter body where there were no signs of adhesive or stretching measured 0.0680", which is within the specification per catheter extrusion product drawing.The od of the catheter body at the points of separation measured 0.0695", which is within the specification per catheter extrusion product drawing.The od of one of the stretched portions of the catheter body measured 0.0490", which is not within the specification per catheter extrusion product drawing.The catheter was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "if 80 cm guidewire is used, insert guidewire into distal lumen until soft tip of guidewire extends beyond catheter tip." a lab inventory 0.035" guide wire (measured 0.033") was inserted through the distal lumen.The guide wire met resistance where the catheter body narrows and was not able to advance through.Manufacturing was contacted as a part of this complaint investigation regarding the non-conformances found during the device history record review.They stated the stretching of the catheter due to the extrusion process could contribute to the reduction of the inner diameter, outer diameter, and wall width which could then result in the catheter body to break/fracture when pulled.Therefore, manufacturing extrusion likely caused or contributed to this event.A device history record review was performed, and there were two potential findings.Non-conformances initiated in regard to "swg /catheter resistance - kinked".The non-conformances addresses an elongation of the catheter extrusion body, and the probable cause was uneven pulling of the extrusion during the extrusion process resulting in the catheter body to stretch.Portions of the returned catheter body appeared stretched.The failure mode of this complaint is relevant to the non-conformances identified based on visual and functional analysis of the sample and comments from manufacturing.Non-conformances initiated in regard to "swg / catheter resistance - kinked".The non-conformances addresses guide wire/catheter resistance at the juncture hub of the picc.This was attributed to the use of a core pin with a dimension below specification during molding of the catheter body at the juncture hub.The failure mode of this complaint is not the same as/relevant to the non-conformances identified as the resistance observed during functional testing of the returned sample pertains to the narrowing of the catheter body.The catheter product drawing was reviewed as part of this complaint investigation.The ifu provided with the 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 report of a torn catheter body was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the catheter body was severed towards the distal end.A device history record review was performed, and there was one relevant finding non-conformances regarding uneven pulling of the extrusion during the extrusion process, which resulted in abnormal stretching.Manufacturing stated the stretching of the catheter due to the extrusion process could contribute to the reduction of the inner diameter, outer diameter, and wall thickness which could then result in the catheter body to break/fracture when pulled.Therefore, manufacturing extrusion likely caused or contributed to this event.Non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "the catheter got torn when the user removed the fixing tape during placement.Therefore, it was removed and replaced with a new kit.No harm to the patient occurred." no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW PICC SET: 16 GA X 27 1/2IN
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: azhwan barazenda ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19826194
• Report Number: 9680794-2024-00705
• Device Sequence Number: 21055620
• Product Code: LJS
• UDI-Device Identifier: 10801902094220
• UDI-Public: (01)10801902094220(11)230810(17)280630(10)14F23G0112(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K042126
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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
• Device Catalogue Number: AJ-01671
• Device Lot Number: 14F23G0112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2024
• Supplement Date Received by Manufacturer: 07/30/2024
• Initial Report FDA Received Date: 07/25/2024
• Supplement Report FDA Received Date: 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2023
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Sex: Unknown