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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER INTRAVENOUS CATHETER

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BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER INTRAVENOUS CATHETER Back to Search Results
Catalog Number 381112
Device Problem Device Packaging Compromised (2916)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/10/2017
Event Type  malfunction  
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The expiration dates were omitted from the initial mdr in section. The information for each lot number is as follows: medical device lot #: 5104340. Device manufacture date: 04/30/2015. Medical device expiration date: 04/30/2020. Medical device lot #: 6084421. Device manufacture date: 04/07/2016. Medical device expiration date: 03/31/2021. Medical device lot #: 6209303. Device manufacture date: 08/17/2017. Medical device expiration date: 07/31/2021. Medical device lot #: 5331034. Device manufacture date: 12/15/2015. Medical device expiration date: 11/30/2020. Bd received samples from the customer facility for investigation. The samples were evaluated and the customer's indicated failure mode for packaging not sealed with the incident lot was observed. A review of the manufacturing records was completed for the incident lot and no issues were identified. Based on the investigation results, no root cause from the manufacturing process was identified as a contributor to the reported failure. Complaints received for this device and reported condition will continue to be tracked and trended.
 
Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 5104340, device manufacture date: 04/30/2015, medical device expiration date: medical device lot #: 6084421, device manufacture date: 04/07/2016, medical device expiration date:. Medical device lot #: 6209303, device manufacture date: 08/17/2017, medical device expiration date:. Medical device lot #: 5331034, device manufacture date: 12/15/2015, medical device expiration date:. 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 before use of the bd angiocath¿ iv catheter the sealing part of the package opened without touching. There was no report of injury or medical intervention.
 
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Brand NameBD ANGIOCATH¿ IV CATHETER
Type of DeviceINTRAVENOUS 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 Key7079130
MDR Text Key266384493
Report Number9610048-2017-00077
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K151698
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/30/2020
Device Catalogue Number381112
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/30/2015
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: 12/04/2017 Patient Sequence Number: 1
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