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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE 10ML 25MM 7DMM S/SU NBS
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BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE 10ML 25MM 7DMM S/SU NBS Back to Search Results
Catalog Number 990629
Device Problem Illegible Information (4050)
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.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 25mm 7dmm s/su nbs was illegible.This occurred on 3 occasions.The following information was provided by the initial reporter: unreadable descriptions (lot).The boxes came apparently intact and without any signal of wetting.
 
Manufacturer Narrative
H.6.Investigation: through the analysis of the photo sent by the customer, it is possible to observe the illegible printed batch.A device history review was performed for lot 1174961, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported issue.The label review record, which is carried out to ensure correct printing of information, was analyzed and no defects were found.No request for reprinting of labels related to the claimed box was evidenced.Possible root cause is associated with an entanglement of the box in the part of the equipment that pulls the box for closing.H3 other text : see h.10.
 
Event Description
It was reported that syringe 10ml 25mm 7dmm s/su nbs was illegible.This occurred on 3 occasions.The following information was provided by the initial reporter: unreadable descriptions (lot).The boxes came apparently intact and without any signal of wetting.
 
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Brand Name
SYRINGE 10ML 25MM 7DMM S/SU NBS
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key12550580
MDR Text Key274779465
Report Number3003916417-2021-00312
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 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990629
Device Lot Number1174961
Was Device Available for Evaluation? No
Date Manufacturer Received09/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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