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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED SYRINGE

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BECTON DICKINSON UNSPECIFIED SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problems Bent (1059); Aspiration Issue (2883); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/26/2018
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. Medical device lot #: unknown. Medical device expiration date: unknown. Device manufacture date: unknown. 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 during use of an unspecified syringe when preparing the patient medication, the syringe did not aspirate properly. The user noticed a defect in the syringe body with scratches and a bowed barrel. There was no report of injury or medical intervention.
 
Manufacturer Narrative
Investigation results: the batch history analysis (dhr) was not performed because the catalog number was unknown. Nor was it possible to check maintenance records and quality notifications. No photos or samples were returned by the client for evaluation. It was not possible to carry out an investigation and to determine the root cause for the defect. The production processes are validated according to the defined acceptance criteria. In this way it is not possible to confirm the claim. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Based on the severity, occurrence and quality data analysis for this product family a capa is not necessary.
 
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Brand NameUNSPECIFIED SYRINGE
Type of DeviceUNSPECIFIED
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7280513
MDR Text Key100563291
Report Number2243072-2018-00055
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received02/01/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 02/19/2018 Patient Sequence Number: 1
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