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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS; PISTON SYRINGE Back to Search Results
Catalog Number 304050
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.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 when using the barrel 1cc s/t w/sil no bd logo/tb bns there was leakage.This event occurred 603 times.The following information was provided by the initial reporter.The customer stated: "the syringe is not self-filling.Syringe leaking blood post draw.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.4.Medical device lot #: 9098803.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: 8/4/2019.D.4.Medical device lot #: 0100479.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: 4/9/2020.H.6.Investigation: since no samples displaying the reported condition were received the reported defect could not be confirmed.A device history record review was completed for provided lot number 9098803.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.A device history record review was completed for provided lot number 0100479.A review showed insufficient silicone issue was reported during the production.Product was requalified per applicable acceptable quality limit before production resumed.H3 other text : see h.10.
 
Event Description
It was reported when using the barrel 1cc s/t w/sil no bd logo/tb bns there was leakage.This event occurred 603 times.The following information was provided by the initial reporter.The customer stated: "the syringe is not self-filling.Syringe leaking blood post draw.".
 
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Brand Name
BARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key12522435
MDR Text Key273136766
Report Number1213809-2021-00654
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
NA
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 09/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number304050
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No
Date Manufacturer Received10/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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