MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL; INTRODUCER, CATHETER

Catalog Number ASK-29903-SL1

Device Problems Material Puncture/Hole (1504); Gas/Air Leak (2946)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: catheter was in patient.When the nurse was pulling back for blood, air was coming out.Line was removed and found to have a hole.I have the equipment saved.Additional information.The nurse removed the line as soon as the issue was identified.There was no reported patient harm.

Manufacturer Narrative

(b)(4).The report of a leaking sheath was confirmed through complaint investigation of the returned sample.The customer provided one photo and returned one, sheath assembly for analysis.Signs of use in the form of biological material were observed on the sample.It was observed on the returned sample that a portion of the distal hub was connected to the sheath assembly.It appears that the distal hub had separated.The cath-gard sleeve and proximal hub were not returned.Inquiries to the customer have been made, and the issue will be investigated in another complaint.Visual analysis revealed three holes on the sheath body; two on the ribbed portion and one towards the center of the sheath body.The edges of the holes were smooth and appeared consistent with damage due to contact with a sharp instrument (i.E.Scalpel, scissors, etc).The location of the holes measured 10 mm, 12 mm, and 25 mm via calibrated ruler from the juncture hub.The sheath body length measured 4 3/16" via calibrated ruler from the juncture hub, which is not within the spec ification limits of 4"-4 1/4" per the sheath product drawing.However, the condition of the ribbed portion of the sheath body appears consistent with being stretched by undue force.The sheath body outer diameter measured 0.14720" via calibrated micrometer, which was within the specification limits of 0.147"-0.157" per the sheath product drawing.Functional inspection was performed per the instructions for use (ifu), "to check for proper sheath placement within the vessel, remove side port end cap and attach syringe for aspiration.Flush and connect side port to appropriate line as necessary." a lab inventory syringe filled with water was attached to the side port and flushed.Water leaked out of the holes on the sheath.The ifu provided with the kit informs the user, "do not secure, staple and/or suture directly to outside diameter of device body or extension lines to reduce risk of cutting or damaging the device or impeding device flow.Secure only at indicated stabilization locations." a device history record review based on a potential lot from sales history did not reveal any relevant findings.Based on the customer report that the damage was observed during use and the appearance of the damage, unintentional user error (contact with sharps) likely caused or contributed to this event.Telefl ex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: catheter was in patient.When the nurse was pulling back for blood, air was coming out.Line was removed and found to have a hole.I have the equipment saved.Additional information.The nurse removed the line as soon as the issue was identified.There was no reported patient harm.

• Brand Name: ARROW PSI KIT: 9 FR X 10 CM ANTIMICROBIAL
• Type of Device: INTRODUCER, CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18516052
• MDR Text Key: 333213442
• Report Number: 9680794-2024-00061
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 10801902202335
• UDI-Public: 10801902202335
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K780532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ASK-29903-SL1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED