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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD® SYRINGE 5 ML LL BULK NON-STERILE; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS BD® SYRINGE 5 ML LL BULK NON-STERILE; PISTON SYRINGE Back to Search Results
Catalog Number 301027
Device Problem Missing Information (4053)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/05/2023
Event Type  malfunction  
Event Description
It was reported that the box of bd® syringe 5 ml ll bulk non-sterile was missing information.The following was translated from dutch to english: customer received 1 box without information (blank) - no labels - no item number - no identification.
 
Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.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 the box of bd® syringe 5 ml ll bulk non-sterile was missing information.The following was translated from dutch to english: customer received 1 box without information (blank) - no labels - no item number - no identification.
 
Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history review could not be completed as no batch number was provided.
 
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Brand Name
BD® SYRINGE 5 ML LL BULK NON-STERILE
Type of Device
PISTON 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
jennifer suh
5859 farinon drive
san antonio, TX 78249
8448235433
MDR Report Key17785871
MDR Text Key323906395
Report Number1213809-2023-01047
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number301027
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/04/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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