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 Problems Device Operates Differently Than Expected (2913); Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2017

Event Type  malfunction  

Manufacturer Narrative

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 needle on a bd insyte¿ autoguard¿ shielded iv catheter 22 g x 1 in.Was exposed after the safety was activated.No injury or medical intervention.

Manufacturer Narrative

Our quality engineer was able to confirm the reported complaint after analysis of the claimed product.Assembled lot: 7087506, used in the claimed final product lot: 7122589 of insyte autoguard 22g x 1.00 was analyzed for "needle retraction" and ¿part activation¿ tests, and it was evidenced failure in the activation of the part during the performing of this test.The root cause was determined to be the plug placement station 5.54.4 during assembly of the product.Bd was able to confirm the incident in question.After analysis of the qn/ncmr of the claimed product, it was possible to confirm the complaint of the needle retraction failure.Samples or photos have not received for analysis of the incident in question.Dhr/qn/ncmr review: assembled lot: 7087506, used in the claimed final product lot: 7122589 of insyte autoguard 22g x 1.00 was analyzed for "needle retraction" and ¿part activation¿ tests, and it was evidenced failure in the activation of the part during the performing of this test.Qn/ncmr review: it was evidenced quality notification (qn) # (b)(4) for the defect ¿part activation failed¿, which involves the assembly lot: 7087506.Based on the investigations, the root cause of quality notification # (b)(4) evidenced a failure occurred at the plug placement station 5.54.4 during assembly of the product.

• 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: 6993563
• MDR Text Key: 91363349
• Report Number: 9610048-2017-00059
• 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: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 38182314
• Device Lot Number: 7122589
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2017
• 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