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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/18/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation: samples or photos have not received for analysis of the incident in question. Dhr/ qn/ ncmr review: assembled lot: 7179974, used in the claimed final product lot: 7195922 of insyte autoguard 22g x 1. 00 was analyzed for "needle retraction" and ¿part activation¿ tests, and it was not evidenced failure in the activation of the part during the performing of these tests. However, "catheter over bevel" records have been evidenced that may cause the defect lie distance out of the specification which indirectly may lead to "needle activation failure". Qn/ ncmr review: it was evidenced quality notification (qn) # (b)(4) for the lie distance defect, which involves the assembly lot: 7179974. Although this nonconformity treats the lie distance defect, according to the investigations of this quality notification, the defect may lead to a needle retraction failure as reported in this complaint. After analysis of the qn/ ncmr of the claimed product, it was possible to confirm the complaint of the needle retraction failure. Based on a severity assessment and occurrence it was determined that no capa is required at this time. The complaint was added to the complaint database for trend analysis, which is regularly monitored. Although it has been evidenced the record of the quality notification above mentioned, during the investigations of this complaint it has been verified that the defect of this non-conformity could indirectly lead to the incident in question. However, it was not possible to determinate precisely its root cause to date. For more details check quality notification #: (b)(4).
 
Manufacturer Narrative
(b)(6). A sample is not available for evaluation. However, a no sample investigation and device history record review will be completed. Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported that the safety mechanism of the bd insyte¿ autoguard¿ shielded iv catheter 22 g x 1 in. Failed to function properly. There was no report of exposure, injury or medical interventions.
 
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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 Key6969319
MDR Text Key256226186
Report Number9610048-2017-00044
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 other
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/30/2020
Device Catalogue Number38182314
Device Lot Number7195922
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 Received09/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2017
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: 10/23/2017 Patient Sequence Number: 1
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