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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL SYRINGE; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL SYRINGE; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305207
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.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 bd¿ oral syringe scale markings washed off in water.The following information was provided by the initial reporter: "rns report they are using these syringes for oral morphine and instructing patients/caregivers to submerge the syringe in a cup of water to prevent medicine from crusting at the end of the syringe.The problem patients and caregivers are coming across is that the markings on the syringes are disappearing and they are no longer able to use the syringe because they¿re unable to determine the amount of remaining medicine.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.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 bd¿ oral syringe scale markings washed off in water.The following information was provided by the initial reporter: "rns report they are using these syringes for oral morphine and instructing patients/caregivers to submerge the syringe in a cup of water to prevent medicine from crusting at the end of the syringe.The problem patients and caregivers are coming across is that the markings on the syringes are disappearing and they are no longer able to use the syringe because they¿re unable to determine the amount of remaining medicine.".
 
Event Description
It was reported that the bd¿ oral syringe scale markings washed off in water.The following information was provided by the initial reporter: "rns report they are using these syringes for oral morphine and instructing patients/caregivers to submerge the syringe in a cup of water to prevent medicine from crusting at the end of the syringe.The problem patients and caregivers are coming across is that the markings on the syringes are disappearing and they are no longer able to use the syringe because they¿re unable to determine the amount of remaining medicine.".
 
Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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¿ ORAL SYRINGE
Type of Device
LIQUID MEDICATION DISPENSER
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 Key13005136
MDR Text Key285405496
Report Number1213809-2021-00815
Device Sequence Number1
Product Code KYW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305207
Device Lot Number1025948
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2022
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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