MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH BASIC 20GAX8CM; CATHETER, INTRAVASCULAR, THERAP.

Catalog Number EDC-00820-B

Device Problems Material Fragmentation (1261); Physical Resistance (2578)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Distal tip of catheter sheared off.During placement, the nurse gained access, saw flash, deployed wire with no resistance.When threading the catheter over the needle, she met resistance and then pulled the catheter back over the needle while the needle was still under the patient's skin.The nurse was unsuccessful with insertion and when she pulled everything out of the patient, she noticed the distal tip of catheter was missing.An x-ray was taken and found distal tip of catheter in patient's arm, not in the vasculature.It was decided that it was too risky to remove and left catheter in patient's subcutaneous tissue.When discussing insertion technique with nurse, it was explained that there is a risk of shearing the distal tip of the catheter off when pulling the catheter back over the needle.No patient harm reported.

Manufacturer Narrative

Qn# (b)(4).The customer returned a catheter assembly from an endurance device for evaluation.The catheter was returned secure within the juncture hub advancer.The separated portion of the catheter was not returned.Visual examination of the catheter body confirmed the distal tip had separated and was not returned.The separation point on the catheter was smooth/angled and was consistent with damage resulting from contact with the needle bevel.Dried blood was observed within the catheter body but no other damage to the catheter was observed.The catheter body length measured 54 mm; therefore, approximately 31 mm of the catheter is missing based on the nominal value of 85 mm per catheter assembly product drawing.The catheter body inner and outer diameters were measured and were found to be within specification.A lab inventory endurance device with a needle cannula of the same size diameter was advanced through the catheter assembly to functionally test the catheter.The needle cannula was able to advance within the catheter with minimal resistance.The catheter was flushed with water and functioned as expected.A device history record review was performed on the device including the catheter and needle and no manufacturing issues were identified.The instructions-for-use (ifu) supplied with this kit cautions the user "always keep needle/handle stationary while threading catheter.Do not retract needle/handle while threading catheter.Failure to keep needle/handle stationary may prevent catheter from threading into vessel." the ifu also contains the warning "do not attempt to advance needle back into catheter after catheter is partially threaded off needle to reduce risk of catheter damage." the customer report of the distal end of the catheter shearing off was confirmed through visual examination of the confirmed sample.Dimensional testing revealed that approximately 31 mm of the catheter was separated during use.The separation point on the catheter was consistent with damage due to contact with the needle bevel.The catheter met all relevant dimensional/functional requirements and no manufacturing issues were identified during a device history record review.Based on the condition of the returned sample and the customer report, it was determined that operational context caused or contributed to this event.

Event Description

Distal tip of catheter sheared off.During placement, the nurse gained access, saw flash, deployed wire with no resistance.When threading the catheter over the needle, she met resistance and then pulled the catheter back over the needle while the needle was still under the patient's skin.The nurse was unsuccessful with insertion and when she pulled everything out of the patient, she noticed the distal tip of catheter was missing.An x-ray was taken and found distal tip of catheter in patient's arm, not in the vasculature.It was decided that it was too risky to remove and left catheter in patient's subcutaneous tissue.When discussing insertion technique with nurse, it was explained that there is a risk of shearing the distal tip of the catheter off when pulling the catheter back over the needle.No patient harm reported.

• Brand Name: ARROW EXT DWELL CATH BASIC 20GAX8CM
• Type of Device: CATHETER, INTRAVASCULAR, THERAP.
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7517931
• MDR Text Key: 108375635
• Report Number: 1036844-2018-00146
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: EDC-00820-B
• Device Lot Number: 13F17K0266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/16/2017
• 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