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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE¿ MANUAL NEEDLE GUARD SYRINGE

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BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE¿ MANUAL NEEDLE GUARD SYRINGE Back to Search Results
Catalog Number 47436030
Device Problems Break (1069); Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 before use, a bd ultrasafe¿ manual needle guard malfunctioned as ¿the needle guard is broken¿ there was no report of injury or medical intervention reported.
 
Manufacturer Narrative
Investigation results: the customer issued a complaint for a detached syringe from needle guard detected by end user. A 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 batch involved in this complaint meets all acceptable quality levels (aqls), was 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 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. 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 most likely cause was that the syringe became detached as it received an external impact after syringe insertion. Bd was unable to confirm any relation of the complaint to the manufacturing process. No further corrective action is necessary at this time.
 
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Brand NameBD ULTRASAFE¿ MANUAL NEEDLE GUARD SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON HUNGARY KFT (BD)
uveggyar utca 3
kornye tatabanya 2851
HU 2851
MDR Report Key7310388
MDR Text Key101508587
Report Number3009081593-2018-00012
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,other
Type of Report Initial,Followup
Report Date 03/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2019
Device Catalogue Number47436030
Device Lot Number5295223
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/09/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/02/2018 Patient Sequence Number: 1
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