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

Model Number 381823

Device Problem Retraction Problem (1536)

Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)

Event Date 09/08/2021

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used.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 bd insyte¿ autoguard¿ catheter i.V.Was difficult to activate.The following information was provided by the initial reporter, translated from (b)(6): "safety device of insyte n°22 showing resistance to being activated, piercing the employee's finger.".

Manufacturer Narrative

Correction: b1: adverse type: adverse event and product problem.B1: event attributed to: required invention.B5: describe event or problem: it was reported bd insyte¿ autoguard¿ catheter i.V.Was difficult to activate.The following information was provided by the initial reporter, translated from portuguese: "safety device of insyte n°22 showing resistance to being activated, piercing the employee's finger." was there a need for medical intervention due to what happened (administration of medications, etc)? (detail) there was a need for medical intervention and drug prophylaxis with antiretroviral drugs was started." h1: type of reportable events: serious injury.H5: imdrf annex f grid: f2303 medication required.H6: investigation summary; there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.

Event Description

It was reported bd insyte¿ autoguard¿ catheter i.V.Was difficult to activate.The following information was provided by the initial reporter, translated from portuguese: "safety device of insyte n°22 showing resistance to being activated, piercing the employee's finger." was there a need for medical intervention due to what happened (administration of medications, etc)? (detail) there was a need for medical intervention and drug prophylaxis with antiretroviral drugs was started.¿.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ CATHETER I.V.
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12583951
• MDR Text Key: 274969171
• Report Number: 9610048-2021-00134
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• 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: 0216345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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 Outcome(s): Required Intervention