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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML SALINE FILL CHINA SP

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BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 3ML SALINE FILL CHINA SP Back to Search Results
Catalog Number 306593
Device Problem Short Fill (1575)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/21/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that the syringe 3ml saline fill china sp experienced pre-filled syringe having the incorrect fill -less than design specifications.The following information was provided by the initial reporter: there is basically no pre-filling liquid in the pre-filling, and the patient almost pushed it into the vein of the patient when the tube was sealed.Fortunately, the nurse pulled it back in time after finding it, and it did not push into the patient's blood vessel, and did not cause major damage.
 
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Brand Name
SYRINGE 3ML SALINE FILL CHINA SP
Type of Device
SYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key10840128
MDR Text Key216870366
Report Number1911916-2020-01028
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 10/30/2020
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 Other
Device Expiration Date04/30/2022
Device Catalogue Number306593
Device Lot Number9112747
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/20/2020
Initial Date FDA Received11/13/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2019
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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