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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD ORAL DISPENSING SYRINGE; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS BD ORAL DISPENSING SYRINGE; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305210
Device Problem Leak/Splash (1354)
Patient Problem No Patient Involvement (2645)
Event Date 09/22/2020
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).
 
Event Description
It was reported that 3 bd¿ oral dispensing syringes had cracked plungers before use.The following information was provided by the initial reporter: "following quality inspection on this batch there have been 3 critical defects found within the 1250 samples taken, resulting in a failed inspection.The 3 syringes which failed with critical faults were due to cracked plungers".
 
Event Description
It was reported that 3 bd¿ oral dispensing syringes had cracked plungers before use.The following information was provided by the initial reporter: "following quality inspection on this batch there have been 3 critical defects found within the 1250 samples taken, resulting in a failed inspection.The 3 syringes which failed with critical faults were due to cracked plungers".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: evaluation? yes.D.10.Returned to manufacturer on: (b)(6)2020.H.6.Investigation: two photos and three loose 3ml oral syringes were received and evaluated.It was observed all three of the syringes had a single cracked plunger rod rib.In each instance the crack was located approximately 1.5" below the thumb rest.The three cracked plunger rods were rejectable per product specification.Machine logs were reviewed as part of this investigation with nothing related to the defect reported.Potential root cause for the cracked plunger rod defect is associated with the assembly process.It may have been due to a jam in the plunger rod rail.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 DISPENSING SYRINGE
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key10708202
MDR Text Key213696458
Report Number1213809-2020-00727
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 distributor,foreign,other
Type of Report Initial,Followup
Report Date 11/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305210
Device Lot Number0048473
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/26/2020
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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