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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 Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/01/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: na. 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 barrel 1cc s/t w/sil no bd logo/tb bns had foreign matter. The following information was provided by the initial reporter: it was reported by the distributor, the doctors had a problem with the return of blood and difficulty performing their blood gas. The customer(s) is/are alleging an excessive amount of silicone in the barrel. Email verbatim: when the box was opened, the doctors had a problem with the return of blood and had great difficulty performing their blood gas. Based on the verbatim from field complaints it was not clear to our investigative team at the plant what the issue was with our syringe barrel. During our conference call on september 3rd the following was described to us. That the customer(s) is/are alleging an excessive amount of silicone in the 304050 barrel - which is having 2 effects: it is clogging your venting media which inhibits/prevents air from exiting your product (a pre-set arterial blood gas syringe) and therefore from filling with the correct amount of blood; and, excess silicone also migrates to the outside of the luer tip which causes the needle to disengage from the syringe. In this application, the plunger is set to a predetermined fill point, the stick is made and air is supposed to exit the syringe via the venting media (being forced out by the arterial pressure), and thereby filling the barrel interior to the pre-set plunger position.
 
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Brand NameBARREL 1CC S/T W/SIL NO BD LOGO/TB BNS
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer (Section G)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12554120
MDR Text Key274572368
Report Number1213809-2021-00682
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number304050
Device Lot Number0286461
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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