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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL DISPENSING SYRINGE 3 ML
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BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL DISPENSING SYRINGE 3 ML Back to Search Results
Catalog Number 305210
Device Problem Device Markings/Labelling Problem (2911)
Patient Problems Overdose (1988); Underdose (2542)
Event Date 01/01/2019
Event Type  malfunction  
Manufacturer Narrative
There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that during use of the unspecified oral syringe the syringes are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.As reported."these syringes are difficult to accurately read once they are filled with liquid.Several staff have reported that once a fluid is drawn up into the syringe, the black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.This is a general concern about the products usability and therefore not lot specific.".
 
Manufacturer Narrative
H.6.Investigation summary: 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 could not be performed as lot number was unknown.
 
Event Description
It was reported that during use of the bd¿ oral dispensing syringe 3 ml the syringes are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.The following information was provided by the initial reporter: "these syringes are difficult to accurately read once they are filled with liquid.Several staff have reported that once a fluid is drawn up into the syringe, the black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.This is a general concern about the products usability and therefore not lot specific.".
 
Manufacturer Narrative
Date of event: (b)(6) 2019.Medical device brand name: bd¿ oral dispensing syringe 3 ml.Medical device type kyw.Medical device manufacturer: becton dickinson medical systems canaan, ct.Medical device catalog #: 305210.Manufacturing location: becton dickinson medical systems canaan, ct.Pma / 510(k)#: exempt.
 
Event Description
It was reported that during use of the bd¿ oral dispensing syringe 3 ml the syringes are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.The following information was provided by the initial reporter: "these syringes are difficult to accurately read once they are filled with liquid.Several staff have reported that once a fluid is drawn up into the syringe, the black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.This is a general concern about the products usability and therefore not lot specific.".
 
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Brand Name
BD¿ ORAL DISPENSING SYRINGE 3 ML
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8465984
MDR Text Key140629346
Report Number2243072-2019-00612
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,Followup
Report Date 04/17/2019
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 Number305210
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 03/08/2019
Initial Date FDA Received03/29/2019
Supplement Dates Manufacturer Received03/08/2019
03/08/2019
Supplement Dates FDA Received04/04/2019
04/17/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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