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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE SOLOMED 3ML LL 22X1-1/4 W/SH SLA
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BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE SOLOMED 3ML LL 22X1-1/4 W/SH SLA Back to Search Results
Catalog Number 302633
Device Problems Break (1069); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
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 solomed 3ml ll 22x1-1/4 w/sh sla was cracked.The following information was provided by the initial reporter: drugstore employee reports that when applying the product duoflam he identified that the syringe was cracked at the time of aspiration of the drug.
 
Event Description
It was reported that syringe solomed 3ml ll 22x1-1/4 w/sh sla was cracked.The following information was provided by the initial reporter: drugstore employee reports that when applying the product duoflam he identified that the syringe was cracked at the time of aspiration of the drug.
 
Manufacturer Narrative
H6: investigation summary through the analysis carried out on the photo sent by the customer, it is possible to observe the incident of a cracked barrel, in this way bd confirms the complaint.According to the investigation carried out on the line, it was identified that the potential root cause for the incident was an entanglement caused by the accumulation of barrels in the transfer disc where the barrel is transferred to the manipulator belt.Batch history analysis was performed, quality notifications and maintenance records were verified where no records potentially related to the incident were found.An improvement was made in the transfer discs of the barrels of the 3ml solomed line to avoid the accumulation and possible barrel entanglements in the equipment.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
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Brand Name
SYRINGE SOLOMED 3ML LL 22X1-1/4 W/SH SLA
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key12393147
MDR Text Key268988636
Report Number3003916417-2021-00236
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 09/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302633
Device Lot Number0133532
Was Device Available for Evaluation? No
Date Manufacturer Received09/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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