MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW EXT DWELL CATH DEVICE 18GAX8CM; CATHETER,INTRAVASCULAR,THERAPE

Catalog Number ASK-00818-IVA

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Qn# (b)(4).Uf/importer report# (b)(4).

Event Description

According to the medwatch report: "attempted to place an ultrasound guided iv via 18g teleflex iv in the right forearm.Iv was inspected and primed before insertion.Iv advanced and confirmed with blood return and ultrasound that it was in the vein.Guide wire threaded through without issue or resistance.Resistance was met while attempting to thread the catheter in, and per the ultrasound something looked irregular.Iv was removed, noticed while disengaging the needle that part of the catheter tip was missing, about.5in, rest of the iv was intact".

Manufacturer Narrative

Qn# (b)(4).Uf/importer report# (b)(4).Additional information received from customer indicates the patient was taken to the or by the vascular surgeon and the tip of the catheter was found to be in the subcutaneous tissue.The tip was removed.It was also reported that the patient was in stable condition post procedure.Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

According to the medwatch report: "attempted to place an ultrasound guided iv via 18g teleflex iv in the right forearm.Iv was inspected and primed before insertion.Iv advanced and confirmed with blood return and ultrasound that it was in the vein.Guide wire threaded through without issue or resistance.Resistance was met while attempting to thread the catheter in, and per the ultrasound something looked irregular.Iv was removed, noticed while disengaging the needle that part of the catheter tip was missing, about.5in, rest of the iv was intact".

• Brand Name: ARROW EXT DWELL CATH DEVICE 18GAX8CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 10660075
• MDR Text Key: 217099269
• Report Number: 9680794-2020-00400
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K151513
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: ASK-00818-IVA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR
• Patient Weight: 119