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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 27X1/2 RB; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 27X1/2 RB; PISTON SYRINGE Back to Search Results
Model Number 309623
Device Problem Misconnection (1399)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2022
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd syringe 1ml s/t w/ndl 27x1/2 rb separation during use occurred.There was no report of patient impact.The following information was provided by the initial reporter: we are having an issue with the needle coming off the syringe when taking the cap off to draw up tuberculin and with the needle coming off while injecting into the patient.
 
Event Description
It was reported while using bd syringe 1ml s/t w/ndl 27x1/2 rb separation during use occurred.There was no report of patient impact.The following information was provided by the initial reporter: we are having an issue with the needle coming off the syringe when taking the cap off to draw up tuberculin and with the needle coming off while injecting into the patient.
 
Manufacturer Narrative
The following fields have been updated due to additional information: d9: device available for eval?: yes.D9: returned to manufacturer on: 16-nov-2022.H6: investigation summary: it was reported needle are coming off the syringe before and during use.To aid in the investigation, one hundred eighty-one 1ml syringes in sealed packaging blisters and forty separated needles were received for evaluation by our quality team.One syringe had tip damage.The condition observed for tip damage is nonconforming per product specification and could occur during the assembly process.The condition observed for needle separation upon package opening is acceptable per product specification.It is recommended to hand tighten the needle on the syringe prior to use.A device history record review was completed for provided material number 309623, lot number 2158096.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2158096 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Tip damage appears to be occurring within our acceptable quality limits; therefore, no further action is required at this time.To date, there have been no other similar events reported for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15874516
MDR Text Key307796885
Report Number1213809-2022-01091
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903096238
UDI-Public(01)30382903096238
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number309623
Device Catalogue Number309623
Device Lot Number2158096
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/07/2022
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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