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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML AMBER; LIQUID MEDICATION DISPENSER
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML AMBER; LIQUID MEDICATION DISPENSER Back to Search Results
Catalog Number 305210
Device Problem Delivered as Unsterile Product (1421)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/31/2021
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that syringe oral 3ml amber had sterility issues.The following information was provided by the initial reporter: microbial testing of 3 ml oral syringes has returned out of specification results of 172 cfu/10 syringes (tamc specification limit 102/10 syringes).
 
Event Description
It was reported that syringe oral 3ml amber had sterility issues.The following information was provided by the initial reporter: microbial testing of 3 ml oral syringes has returned out of specification results of 172 cfu/10 syringes (tamc specification limit 102/10 syringes).
 
Manufacturer Narrative
H6: investigation summary: the 3ml oral product associated with this complaint is manufactured and sold as non-sterile.Therefore, sterility testing is not applicable, and no defect is confirmed.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 3ML AMBER
Type of Device
LIQUID MEDICATION DISPENSER
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key11742502
MDR Text Key264493157
Report Number1213809-2021-00276
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 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305210
Device Lot Number0114465
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 03/31/2021
Initial Date FDA Received04/28/2021
Supplement Dates Manufacturer Received05/21/2021
Supplement Dates FDA Received06/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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