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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL S/C 200; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML LL S/C 200; PISTON SYRINGE Back to Search Results
Catalog Number 302995
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/14/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe 10ml ll s/c 200 was missing the expiration date.This occurred on 2800 occasions.The following information was provided by the initial reporter: it was reported that 14 cases do not have a lot or an expiration date printed on them.
 
Event Description
It was reported that syringe 10ml ll s/c 200 was missing the expiration date.This occurred on 2800 occasions.The following information was provided by the initial reporter: it was reported that 14 cases do not have a lot or an expiration date printed on them.
 
Manufacturer Narrative
H6: investigation summary: three photos were received and evaluated.A 400 (200x2) count case label, confirmed to be from batch 8213944 (material 302995), was observed in the photos.One photo showed two individual packages side by side.One package had batch 8213944 and expiration date printed on the top web; one package had no expiration and no batch # printed on its top web.Per applicable graphics drawing, variable print information must be printed on the top web.Current production was evaluated, line technicians and process engineer were interviewed as part of the investigation.The blisterpack printer functioned as expected.Variable print detection system is currently set up for some of the cavities and interrupts process per rejection criteria when packages with improper unique device identifier print are detected.Potential root cause for the missing variable print on package defect is associated with the packaging process: (1) it is possible during one of the top web changes the top web printer was not put in its working condition prior to resuming the production.(2) inadequate variable print verification on packages.Current system does not check every cavity for presence of variable print.Since the production of batch 8213944 (material 302995), variable print was updated to include 2d barcode per regulatory requirements.(1) the current packaging print verification system will be upgraded to include sensors for all package cavities.The 2d barcode will be scanned on every package and product will be auto-rejected if no barcode is detected or it is illegible.Due date: nov 2021.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
SYRINGE 10ML LL S/C 200
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key11972008
MDR Text Key255374697
Report Number1213809-2021-00416
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382903029952
UDI-Public00382903029952
Combination Product (y/n)N
PMA/PMN Number
K980987
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 07/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date07/31/2023
Device Catalogue Number302995
Device Lot Number8213944
Was Device Available for Evaluation? No
Date Manufacturer Received07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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