MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 22GAX6CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number EDC-00622

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889)

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

Event Date 06/13/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint reports a catheter that was placed the previous day seemed to be kinked and fractured the following day.It was reported the line was not flushing easily and had lost blood return.The dressing was changed overnight with no improvement in function.In the morning the nurse pulled back on the line and was able to flush easily with brisk blood return.She removed the dressing and pulled the line out less than 0.5cm.She attempted to flush again and the line was very sluggish.She pulled back about another 0.5cm and aspirated air.She withdrew more of the catheter and noted the catheter appeared to be fractured just below the hub.The line was removed.No patient harm reported.The patient's condition is reported as fine.

Event Description

Customer complaint reports a catheter that was placed the previous day seemed to be kinked and fractured the following day.It was reported the line was not flushing easily and had lost blood return.The dressing was changed overnight with no improvement in function.In the morning the nurse pulled back on the line and was able to flush easily with brisk blood return.She removed the dressing and pulled the line out less than 0.5cm.She attempted to flush again and the line was very sluggish.She pulled back about another 0.5cm and aspirated air.She withdrew more of the catheter and noted the catheter appeared to be fractured just below the hub.The line was removed.No patient harm reported.The patient's condition is reported as fine.

Manufacturer Narrative

Qn# (b)(4).The customer returned one endurance catheter for evaluation.Visual inspection of the endurance catheter revealed the catheter body contained two kinks near the juncture hub and contained a tear in the second kink.The kinks in the catheter were located at 2 mm and 8 mm from the juncture hub.The total length of the catheter body measured 2.5625" which is within specifications of 2.554-2.564" per catheter body drawing.The outer diameter of the catheter body measured 0.03595" which is within specifications of 0.0335-0.0375" per catheter body graphic.The inner diameter of the catheter tip measured 0.022", which is within specifications of 0.0185-0.0225 per catheter graphic.Functional inspection was performed per the instructions for use (ifu).The ifu provided with this kit states, "engage extension line clamp and remove the vent plug from catheter extension line luer hub, attach a 10 ml syringe filled with normal saline for injection, unclamp and check for brisk free-flowing blood return, flush, and reengage extension line clamp." the endurance catheter was connected to a lab inventory water-filled syringe.When the catheter was flushed, water passed through the catheter body and exited out of the distal end and through the tear in the kink near the juncture hub.The manufacturing facility has been previously contacted as part of this complaint investigation.It was stated that in-process inspection includes 100% leak testing of molded pieces to verify catheter structural integrity.The ifu provided with this kit warns the user, "do not force catheter if resistance is encountered during advancement.Do not apply tape, staples, or sutures directly to the catheter body to reduce risk of damaging catheter, impeding catheter flow, or adversely affecting monitoring capabilities.Secure only at indicated stabilization locations." the report of a cut/tear in an endurance catheter was confirmed through complaint investigation.Visual and microscopic examination revealed that the catheter body contained two kinks and a tear in the kink adjacent to the juncture hub.The damage observed was consistent with the device being kinked at the insertion site , which caused a weakening in the material extrusion.Despite the damage, the catheter met all relevant dimensional and functional requirements.Manufacturing engineers have previously been consulted, and stated that this product undergoes in-process inspection which includes 100% leak testing of molded pieces prior to release.Based on the customer report that the defect was observed during use and the appearance of the damage on the returned device, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW EXT DWELL CATH DEVICE 22GAX6CM
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14846465
• MDR Text Key: 295967253
• Report Number: 9680794-2022-00406
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151513
• 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: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EDC-00622
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2022
• 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