MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN.; 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 09/23/2017

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 the safety mechanism on a bd insyte¿ autoguard¿ shielded iv catheter 22 g x 1 in failed to function properly during use.There was no report of injury or medical interventions.

Manufacturer Narrative

Investigation: based on the analysis of the sample returned from the client, it is not possible to confirm the reported defect, since no characteristics were detected in any of the analyzed sample components that could cause an activation failure.In addition, there are no records in production histories, non-conformities or corrective maintenance that could clearly lead to this complaint for the lot involved in this complaint.Based on the investigations of this complaint, it was not possible to assign a root cause for the incident to date since the complaint was not confirmed.Samples/ photos: it was received one sample opened and unused of insyte autoguard 22g x 1.00, catalog number 38182314 from lot: 7122627.After visual analysis of the sample, were no detected damage or characteristics in any of the components (barrel, grip, bottom) of the product that could lead to a failure to activate the safety device.Dhr review: the assembly lot: 7116584, used in the claimed final product lot: 7122627 of insyte autoguard 22g x 1.00 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: there are no qn records of this defect for batches related in this complaint.Unplanned maintenance: 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.Not confirmed: bd was unable to confirm the incident in question.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN.
• 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: 7025520
• MDR Text Key: 92922907
• Report Number: 9610048-2017-00064
• 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: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 38182314
• Device Lot Number: 7122627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2017
• 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