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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE¿ INJECTION SYSTEM NEEDLE GUARD (B-SERIES) PISTON SYRINGE

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BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE¿ INJECTION SYSTEM NEEDLE GUARD (B-SERIES) PISTON SYRINGE Back to Search Results
Catalog Number 47435830
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: 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 that during use a bd ultrasafe injection system needle guard (b-series) safety device failed as "the needle guard detached from the syringe while user attempted to administer the dose. " there was no report of exposure, injury or medical intervention needed.
 
Manufacturer Narrative
Neither sample nor photo was provided to bd medical ¿ pharmaceutical system (bdm-ps) for analysis. Bdm-ps performed a batch history record¿s review (bhr) including a review of all data collected during in process and quality inspections. The batches involved in this complaint meet all acceptable quality levels (aql¿s), were manufactured and released according to applicable procedures and specifications. This device was designed with a low clipping force to accommodate easily all types of syringes during device assembly and so minimizing risk of flange or device breakage. The draw-back of this design is the relatively low retention force. Based on investigation conclusion a syringe can only become detached if syringe capture features (holding clips) of the device or the flange of the syringe get damaged/broken or the syringe receives an impact after syringe insertion which causes it to unclip from the device. The manual needle guards syringe flange holding clips were observed straight and properly aligned. The syringe flange and barrel were not cracked or broken. Based on the deformation seen on one of the holding clips the syringe was unclipped from the device. Therefore, the syringe most likely became detached as it received an external impact after syringe insertion. Based on investigation conclusion the syringe most likely became detached as it was not clipped into the device or the product received an external impact after syringe insertion which caused the syringe to unclip from the device.
 
Event Description
It was reported that during use a bd ultrasafe injection system needle guard (b-series) safety device failed as "the needle guard detached from the syringe while user attempted to administer the dose. " there was no report of exposure, injury or medical intervention needed.
 
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Brand NameBD ULTRASAFE¿ INJECTION SYSTEM NEEDLE GUARD (B-SERIES)
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON HUNGARY KFT (BD)
uveggyar utca 3
kornye tatabanya 2851
HU 2851
Manufacturer (Section G)
BECTON DICKINSON HUNGARY KFT (BD)
uveggyar utca 3
kornye tatabanya 2851
HU 2851
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key7636472
MDR Text Key112448209
Report Number3009081593-2018-00047
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K972878
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date02/29/2020
Device Catalogue Number47435830
Device Lot Number6060087
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 Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/29/2016
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: 06/25/2018 Patient Sequence Number: 1
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