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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE; PISTON SYRINGE Back to Search Results
Model Number 305540
Device Problems Leak/Splash (1354); Fitting Problem (2183)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2022
Event Type  malfunction  
Event Description
It was reported that the bd allergy syringe tray with bd precisionglide¿ permanently attached needle had a loose plunger that caused medication to leak out.The following information was provided by the initial reporter: "consumer reported loose plungers that do not create a seal and allow medication to leak out of syringe barrel.Consumer stated she has been using this item for over 10 years and never had a problem previously.Consumer stated she uses syringes to inject vitamin b12.Consumer stated she has 3 allergy syringe trays all with the same lot # but has only opened & experienced problems with one tray.".
 
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 the bd allergy syringe tray with bd precisionglide¿ permanently attached needle had a loose plunger that caused medication to leak out.The following information was provided by the initial reporter: "consumer reported loose plungers that do not create a seal and allow medication to leak out of syringe barrel.Consumer stated she has been using this item for over 10 years and never had a problem previously.Consumer stated she uses syringes to inject vitamin b12.Consumer stated she has 3 allergy syringe trays all with the same lot # but has only opened & experienced probelms with one tray.".
 
Manufacturer Narrative
H6: investigation summary: since no samples (including photos) were returned for the reported issue of ¿"needle point missing¿ with lot number 9345898 regarding item # 305540 the complaint could not be confirmed, and the root cause is undetermined.A review of the device history record was completed for batch # 9345898.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.As no samples and/or photo(s) were received the investigation concluded that bd was not able to duplicate or confirm the indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.
 
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Brand Name
BD ALLERGY SYRINGE TRAY WITH BD PRECISIONGLIDE¿ PERMANENTLY ATTACHED NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13391849
MDR Text Key284839885
Report Number1920898-2022-00047
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903055402
UDI-Public30382903055402
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,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number305540
Device Catalogue Number305540
Device Lot Number9345898
Was Device Available for Evaluation? No
Date Manufacturer Received02/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/11/2019
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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