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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ENTERAL SYRINGES; GASTROINTESTINAL TUBE AND ACCESSORIES
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BECTON DICKINSON MEDICAL SYSTEMS BD ENTERAL SYRINGES; GASTROINTESTINAL TUBE AND ACCESSORIES Back to Search Results
Model Number 305857
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Event Description
It was reported that the bd enteral syringe experienced scale marking issues.The following information was provided by the initial reporter: no or half erased scale lines on the injector.We cannot scale.
 
Manufacturer Narrative
Investigation summary: one photo of a loose 10ml syringe (p/n (b)(4) was received and evaluated.The print condition observed was non-conforming per product specification.Potential root cause for the ink smearing defect is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1025001 is considered in compliance with our product specification requirements.Furthermore, 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.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.Potential root cause for the ink smearing defect is associated with the marking process.The aql for ink smears is 0.25%.The defective rate identified is 1 out of 419,200 which is 0.0002%.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1025001 is considered in compliance with our product specification requirements.
 
Manufacturer Narrative
Investigation summary: one photo of a loose 10ml syringe (p/n 305857) was received and evaluated.The print condition observed was non-conforming per product specification.Potential root cause for the ink smearing defect is associated with the marking process.These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1025001 is considered in compliance with our product specification requirements.Furthermore, 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.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.Potential root cause for the ink smearing defect is associated with the marking process.The aql for ink smears is 0.25%.The defective rate identified is (b)(4) which is (b)(4).These conditions are occurring at/below their expected frequency.Therefore, no corrective action is required at this time.Batch #1025001 is considered in compliance with our product specification requirements.
 
Event Description
It was reported that the bd enteral syringe experienced scale marking issues.The following information was provided by the initial reporter: no or half erased scale lines on the injector.We cannot scale.
 
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Brand Name
BD ENTERAL SYRINGES
Type of Device
GASTROINTESTINAL TUBE AND ACCESSORIES
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13225973
MDR Text Key285411199
Report Number1213809-2021-00859
Device Sequence Number1
Product Code KNT
UDI-Device Identifier30382903058571
UDI-Public30382903058571
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K112434
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number305857
Device Catalogue Number305857
Device Lot Number1025001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2021
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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