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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD; ANTISTICK SYRINGE
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BECTON DICKINSON HUNGARY KFT (BD) BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD; ANTISTICK SYRINGE Back to Search Results
Catalog Number 47451130
Device Problem Activation Problem (4042)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2023
Event Type  malfunction  
Manufacturer Narrative
H.6.Investigation summary: the customer issued a complaint for can¿t activate problem detected during test at customer.Photos were 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 complaint is registered in bd complaint system and trend analysis will be performed.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer or correlate this symptom with a potential cause linked to bd process.
 
Event Description
It was reported that during use with bd ultrasafe plus¿ passive needle guard the safety guard was not able to be deployed fully.The following information was provided by the initial reporter: the lockout mechanism on the device did not deploy fully following expulsion of the contents of the syringe, leaving the needle exposed.The flexible latches on the body component appear to be deformed/mis-shaped.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 13jul2023.H6: investigation summary.The customer issued a complaint for can¿t activate problem detected during test at customer.Photos were 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 complaint is registered in bd complaint system and trend analysis will be performed.Based on the investigation conclusion, bdm-ps was not able to confirm the symptom perceived by the customer or correlate this symptom with a potential cause linked to bd process.
 
Event Description
It was reported that during use with bd ultrasafe plus¿ passive needle guard the safety guard was not able to be deployed fully.The following information was provided by the initial reporter: the lockout mechanism on the device did not deploy fully following expulsion of the contents of the syringe, leaving the needle exposed.The flexible latches on the body component appear to be deformed/mis-shaped.
 
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Brand Name
BD ULTRASAFE PLUS¿ PASSIVE NEEDLE GUARD
Type of Device
ANTISTICK 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
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17376926
MDR Text Key319662296
Report Number3009081593-2023-00012
Device Sequence Number1
Product Code MEG
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/27/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number47451130
Device Lot Number1320204
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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