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U.S. Department of Health and Human Services

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

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN. INTRAVASCULAR CATHETER Back to Search Results
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
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.
 
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.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN.
Type of DeviceINTRAVASCULAR 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 Key6993563
MDR Text Key253158349
Report Number9610048-2017-00059
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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 Received11/01/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2020
Device Catalogue Number38182314
Device Lot Number7122589
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/01/2017 Patient Sequence Number: 1
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