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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO SYRINGE 3ML LL SYRINGE ONLY MX BUN; PISTON SYRINGE
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BECTON DICKINSON DE MEXICO SYRINGE 3ML LL SYRINGE ONLY MX BUN; PISTON SYRINGE Back to Search Results
Catalog Number 302545
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/09/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe 3ml ll syringe only mx bun barrel was cracked.The following information was provided by the initial reporter, translated from spanish to english: "syringe with defect in its barrel.Crack in its structure.".
 
Event Description
It was reported that the syringe 3ml ll syringe only mx bun barrel was cracked.The following information was provided by the initial reporter, translated from spanish to english: "syringe with defect in its barrel.Crack in its structure.".
 
Manufacturer Narrative
H6: investigation summary: photos received for investigation, upon observation the barrel appears cracked, bd confirms the complaint.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.It is not possible to appreciate in detail the type of mark that this fracture generates in order to carry out a more robust analysis, during the production line tour, no parts of the equipment or of the process were detected where the defect could be reproducible.Possible root cause is associated with misalignment transfer discs.Actions have been carried out to contain fault generation fractured barrel.Based on the batch manufacturing dates, actions have been taken to contain the generation of the defect cracked barrel, with follow-up in the quality system and concluded in the month of (b)(6) 2020, highlighting that the batch reported in this claim was manufactured prior to the implementation and closing of this quality notification.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.
 
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Brand Name
SYRINGE 3ML LL SYRINGE ONLY MX BUN
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
MDR Report Key12140282
MDR Text Key260837713
Report Number9614033-2021-00077
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 08/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302545
Device Lot Number0258897
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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