MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD INSYTE-N AUTOGUARD; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number 381511

Device Problems Material Fragmentation (1261); Difficult to Insert (1316); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/06/2021

Event Type  malfunction  

Event Description

Multiple complaints from nursing staff of bd intravascular catheters splintering or splitting.Upon single attempt, the plastic sheath of cahtheter splinters when needle is re-introduced.On initial insertion, there have been complaints of needle not cannulating the skin/vein easily and resistance is met.Iv infiltrates appear to be trending up.Below is some of the descriptions that have been shared: the catheter is hard to cannulate the skin "almost as the skin is tough and i know it is not"."i meet resistance if i need to reintroduce the needle into the catheter"."it doesn't seem to thread right"."it doesn't feel right when i puncture the skin"."when i pull it out the catheter is splintered or torn" (after iv attempt was unsuccessful).

• Brand Name: BD INSYTE-N AUTOGUARD
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11494550
• MDR Text Key: 240081357
• Report Number: 11494550
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 381511
• Device Catalogue Number: 381511
• Device Lot Number: 0195143 0080379 0119474 026501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 DA