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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 10ML CLEAR; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 10ML CLEAR; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305219
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/15/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that syringe oral 10ml clear caps are falling off.The following information was provided by the initial reporter: material# 305219, lot#0087083.It was reported caps are falling off.Called consumer to follow up with product complaint.Consumer stated the caps are falling off of his oral syringes.Stated either the caps are too big or the syringes are too small.Confirmed demographic information and also provided pharmacy information for replacement.
 
Event Description
It was reported that syringe oral 10ml clear caps are falling off.The following information was provided by the initial reporter: material# 305219, lot#0087083.It was reported caps are falling off.Called consumer to follow up with product complaint.Consumer stated the caps are falling off of his oral syringes.Stated either the caps are too big or the syringes are too small.Confirmed demographic information and also provided pharmacy information for replacement.
 
Manufacturer Narrative
Investigation summary: one loose 10ml oral syringe with tip cap was received and evaluated.No visual defects were observed.Pressure testing of the tip cap was performed.The results indicated the product was within specification.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
SYRINGE ORAL 10ML CLEAR
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key11312021
MDR Text Key233557770
Report Number1213809-2021-00069
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 consumer,other
Type of Report Initial,Followup
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305219
Device Lot Number0087083
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/29/2021
Date Manufacturer Received03/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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