MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number 38182314

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd insyte autoguard shielded iv catheters had safety devices that did not work.This occurred on 3 separate occasions but the date/time and or patient information is unknown.

Manufacturer Narrative

Investigation: bd was able to verify the report of needle retraction failure.Although no samples were received for analysis after analysis of batch history and nonconformities, it was evidenced quality notification of activation failure of the part that due to misalignment of zone # 5, station 5.54.4, caused a damage in the component "grip" and consequent caused the failure confirmation of this complaint.A maintenance order was performed the centralizing of bars and alignment of the pins of station 5.54.4 on (b)(6) 2018.Bd was unable to verify the report of catheter broke/separated.In addition, no records were found that could cause this claim during the analysis of batch history and non-conformities, without samples or photos for analysis.

Event Description

It was reported that bd insyte¿ autoguard¿ shielded iv catheters had safety devices that did not work.This occurred on 3 separate occasions but the date/time and or patient information is unknown.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 8324407
• MDR Text Key: 135754499
• Report Number: 9610048-2019-00108
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 38182314
• Device Lot Number: 8092614
• Initial Date Manufacturer Received: 01/17/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 01/17/2019
• Supplement Dates FDA Received: 02/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other