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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD 20 ML SYRINGE WITH NEEDLE
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BECTON DICKINSON, S.A. BD 20 ML SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 301948
Device Problem Fungus in Device Environment (2316)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/24/2019
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.
 
Event Description
It was reported that foreign matter was found before use with a bd¿ 20 ml syringe with needle.The following information was provided by the initial reporter, "on (b)(6) 2019, a complaint was received from head nurse of the supply room of west china hospital, which reflected that the material no.301948 syringe had mildew.The information of about one disposable sterile syringe involved in the complaint was material no.301948, batch no.1901137, and the period of validity was 2023.12.31.".
 
Manufacturer Narrative
H.6.Investigation: bd has been provided with photos and the affected sample for catalog 301948 lot 1901137 to investigate for this record.Visual examination of the sample identifies the foreign matter as grease allocated between the barrel and plunger.As a result, bd was able to verify the reported issue.The presence of this grease contamination was due to an incorrect use of it during the assembly machine maintenance process.An incorrect practice during this maintenance allowed the presence of this grease in the machine which finally ended inside the syringe.The device history review showed no indication of the alleged defect.
 
Event Description
It was reported that foreign matter was found before use with a bd¿ 20 ml syringe with needle.The following information was provided by the initial reporter, "on (b)(6) 2019, a complaint was received from head nurse of the supply room of west china hospital, which reflected that the material no.301948 syringe had mildew.The information of about one disposable sterile syringe involved in the complaint was material no.301948, batch no.1901137, and the period of validity was (b)(6) 2023.".
 
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Brand Name
BD 20 ML SYRINGE WITH NEEDLE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
MDR Report Key9587719
MDR Text Key190692722
Report Number3002682307-2019-00722
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date12/31/2023
Device Catalogue Number301948
Device Lot Number1901137
Date Manufacturer Received12/24/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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