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

Catalog Number 38182314

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 05/05/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the safety mechanism of a bd insyte¿ autoguard¿ shielded iv catheter was not working properly.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: samples/ photos: samples have not received for analysis of the incident in question.Dhr review: the following assembly batch used in the final claimed product list 7244583 was analyzed: the final assembly lot: 7241767 assembled in the period from 09/01/2017 to 09/13/2017.The batch was analyzed for "needle retraction" and ¿part activation¿ tests, and it was not evidenced record of failure of activation of the part during the analysis of these batches.Qn/ ncmr review: no records of quality notification or reports of non-conformity that could lead to incidents in to the lot involved in this complaint were evidenced.The corrective maintenance history in the manufacturing period of the assembly lot involved in this complaint was evaluated and no records were recorded that could clearly indicate a failure of the activation of the part.Investigation conclusion: not confirmed: bd was unable to confirm the claimed defect.Since samples containing the defect claimed are not available for review, this complaint was not confirmed.In addition, there are no non-conformities or corrective maintenance in the lots involved in this complaint, which could confirm the defect claimed without presence of samples.

• 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
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7534558
• MDR Text Key: 108997624
• Report Number: 9610048-2018-00060
• 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: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 38182314
• Device Lot Number: 7244592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2017
• 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): Other