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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE ORAL 10ML AMBER; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE ORAL 10ML AMBER; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305209
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/09/2019
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: 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 during was discovered that the scale markings print was faded with a bd syringe oral 10ml amber.This occurred on 5 separate occasions, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: print on syringe faded.
 
Event Description
It was reported that during was discovered that the scale markings print was faded with a bd syringe oral 10ml amber.This occurred on 5 separate occasions, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: print on syringe faded.
 
Manufacturer Narrative
H.6.Investigation: two photos were received and evaluated.One photo displayed a 100-count label confirmed to be from batch 7208629 (p/n 305209).One photo showed two loose 10ml oral syringes with spots of missing print.Both syringes in the photo were missing at least half of one item and were rejectable per product specification.Potential root cause for the missing print defect is associated with the marking process.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.
 
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Brand Name
BD SYRINGE ORAL 10ML AMBER
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8831999
MDR Text Key153843639
Report Number1213809-2019-00768
Device Sequence Number1
Product Code KYW
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 09/05/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305209
Device Lot Number7208629
Initial Date Manufacturer Received 07/09/2019
Initial Date FDA Received07/26/2019
Supplement Dates Manufacturer Received07/09/2019
Supplement Dates FDA Received09/05/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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