MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD INSYTE CATHETER

Catalog Number UNKNOWN

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Investigation summary: as no physical sample, material and/or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.Capa is not required at this time.

Event Description

It was reported that unspecified bd¿ insyte catheter was damaged and separated, causing leakage.The following information was provided by the initial reporter: it is reported customer experienced separation, leaking, needle being too long and flimsy.Verbiage received, - iv equipment failure: iv becomes unhooked for the hub, bleeding from the site.Iv cannula and needle too long and flimsy at the 2nd iv start.Blood flash was undistinguished, and iv needed to be attempted 3 times before successful start.Adhesive window dressing has a slit which does not cover the connection between cannula hub and tubing extension, allowing it to become disconnected and bleeding from the iv site when pt was alone in the room.

• Brand Name: UNSPECIFIED BD INSYTE CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12250207
• MDR Text Key: 264553366
• Report Number: 2243072-2021-01981
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 119 YR