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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL VITAMIN K1 - HEMIN SOLUTION; SUPPLEMENT, CULTURE MEDIA
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BECTON, DICKINSON & CO. (SPARKS) BD BBL VITAMIN K1 - HEMIN SOLUTION; SUPPLEMENT, CULTURE MEDIA Back to Search Results
Catalog Number 212354
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/17/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that sample leakage occurred with the bd bbl¿ vitamin k1 - hemin solution prior to use.There was no report of patient impact.The following information was provided by the initial reporter: the product was returned.The outer was dry looking but when opened the content was spilled.
 
Manufacturer Narrative
H6: after further evaluation of the complaint, it has been determined that the previously submitted mfr report# 1119779-2021-00163 was sent in error.This complaint is not mdr reportable.There was no report of serious injury, medical intervention, or reportable.This particular event would require the user to acquire replacement material in order to use as intended.This event results in user dissatisfaction.These physical defects do not negatively affect the results, and would render the product unusable.This is unlikely to cause serious injury.
 
Event Description
It was reported that sample leakage occurred with the bd bbl¿ vitamin k1 - hemin solution prior to use.There was no report of patient impact.The following information was provided by the initial reporter: the product was returned.The outer was dry looking but when opened the content was spilled.
 
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Brand Name
BD BBL VITAMIN K1 - HEMIN SOLUTION
Type of Device
SUPPLEMENT, CULTURE MEDIA
Manufacturer (Section D)
BECTON, DICKINSON & CO. (SPARKS)
7 loveton circle
sparks MD 21152
MDR Report Key11244892
MDR Text Key229370149
Report Number1119779-2021-00163
Device Sequence Number1
Product Code JSK
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
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 06/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/27/2021
Device Catalogue Number212354
Device Lot Number0295654
Was Device Available for Evaluation? No
Date Manufacturer Received06/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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