MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. INSYTE AUTOGUARD BL 22GA X 1.0IN; CATHETER

Model Number 381823

Device Problem Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 01/29/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter zip: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that insyte autoguard bl 22ga x 1.0in needle would not retract.This occurred on 2 occasions.The following information was provided by the initial reporter: customer reported an accident at work with a collaborator in the endoscopy sector, where the same was punctured with the bd catheter, as it locked the safety device when activated, not retracting the needle for the protection camera.Additional information: customer informed that there was no medical intervention, however, the employee is using prophylactic medication.The sample is available (contaminated).

Event Description

It was reported that insyte autoguard bl 22ga x 1.0in needle would not retract.This occurred on 2 occasions.The following information was provided by the initial reporter: customer reported an accident at work with a collaborator in the endoscopy sector, where the same was punctured with the bd catheter, as it locked the safety device when activated, not retracting the needle for the protection camera.Additional information: customer informed that there was no medical intervention, however, the employee is using prophylactic medication.The sample is available (contaminated).

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 0216348, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that there was a failure in the safety device.Based off the provided photo the engineer was able to verify the reported issue.However, without a physical sample available for investigation a definitive root cause could not be determined.H3 other text : see h.10.

• Brand Name: INSYTE AUTOGUARD BL 22GA X 1.0IN
• Type of Device: CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 11408208
• MDR Text Key: 234616506
• Report Number: 9610048-2021-00029
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/08/2021

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: 07/31/2023
• Device Model Number: 381823
• Device Catalogue Number: 38182314
• Device Lot Number: 0216348
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/05/2021
• Initial Date FDA Received: 03/03/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other