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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD SYRINGE WITH NEEDLE

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BECTON DICKINSON, S.A. BD SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 301947
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 04/12/2019
Event Type  malfunction  
Manufacturer Narrative
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 that bd¿ syringe with needle had foreign matter in the barrel.The following information was provided by the initial reporter: before using, it was found that the end of barrel with black foreign matter.
 
Event Description
It was reported that bd¿ syringe with needle had foreign matter in the barrel.The following information was provided by the initial reporter: before using, it was found that the end of barrel with black foreign matter.
 
Manufacturer Narrative
Investigation: bd has been provided with a photo for catalog 301947 lot 1810136 to investigate for this record.Bd was able to see an insect allocated in the external part of the barrel, verifying the reported issue.Based on the feedback provided, the insect could be introduced in the syringe during storage after production or during production in the assembly room ending at the primary packaging machine.The most probable root cause is that this issue happened during the transport of material during assembly.Dhr showed no indication of the alleged defect.
 
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Brand Name
BD SYRINGE WITH NEEDLE
Type of Device
SYRINGE WITH NEEDLE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
cr mequinenza
s/n
fraga
MDR Report Key8573394
MDR Text Key144979324
Report Number3002682307-2019-00284
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903019472
UDI-Public382903019472
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 05/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2023
Device Catalogue Number301947
Device Lot Number1810136
Initial Date Manufacturer Received 04/17/2019
Initial Date FDA Received05/02/2019
Supplement Dates Manufacturer Received04/17/2019
Supplement Dates FDA Received05/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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