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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 305122
Device Problem Complete Blockage (1094)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2022
Event Type  malfunction  
Event Description
It was reported that the bd precisionglide¿ needle was blocked during the steroid injection.The following information was provided by the initial reporter: "i was the patient.My provider was attempting to give me a steroid injection in my wrist but could not get the medication to come out through the bd 25g needle.She tried a second needle with the same result.She then had to get a 22g needle and the medication was successfully injected.She told me this has happened to her before and to another provider at the office.As the patient, i had three needlesticks when one should have been sufficient.The provider was inconvenienced and embarrassed.The provider wondered if it was the needle malfunctioning, or the thickness of the steroid preparation itself that caused the issue.".
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary it was reported medication would not come out of the needle.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a packaging blister top web indicating the material and lot numbers.No other information could be obtained by the photo.As a sample was not returned, a thorough sample investigation could not be completed.A device history record review was completed for provided material number 305122, lot number 1335532.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with no sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.
 
Event Description
It was reported that the bd precisionglide¿ needle was blocked during the steroid injection.The following information was provided by the initial reporter: "i was the patient.My provider was attempting to give me a steroid injection in my wrist but could not get the medication to come out through the bd 25g needle.She tried a second needle with the same result.She then had to get a 22g needle and the medication was successfully injected.She told me this has happened to her before and to another provider at the office.As the patient, i had three needlesticks when one should have been sufficient.The provider was inconvenienced and embarrassed.The provider wondered if it was the needle malfunctioning, or the thickness of the steroid preparation itself that caused the issue.".
 
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Brand Name
BD PRECISIONGLIDE¿ NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key16064854
MDR Text Key308466245
Report Number1911916-2022-00783
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K021475
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/06/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number305122
Device Lot Number1335532
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/09/2022
Initial Date FDA Received12/28/2022
Supplement Dates Manufacturer Received01/06/2023
Supplement Dates FDA Received01/23/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2021
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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