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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10CC S/T WOS STERILE WATER BNS

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BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 10CC S/T WOS STERILE WATER BNS Back to Search Results
Catalog Number 304086
Device Problems Contamination /Decontamination Problem (2895); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/30/2019
Event Type  malfunction  
Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 8023613. Medical device expiration date: n/a. Device manufacture date: 2018-01-23. Medical device lot #: 8025589. Medical device expiration date: n/a. Device manufacture date: 2018-01-25. " (b)(6). 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 bd¿ syringe 10cc s/t wos sterile water bns had no water in syringe upon opening the package on 2 different batches. Initial email rcvd from bard malaysia: "please be informed that we have received multiple customer complaints regarding short fill (to date 15 complaints have been launched). Upon evaluation of 4 samples returned, foreign matter (plastic debris) from the plunger was found stuck or trapped in between the plunger tip and inner wall of the barrel. It is believed that this has caused void or channel from where water leak post manufacturing. Additional information: same failure modes detected for all 4 samples which we have received. Plastic debris material matches material of plunger (confirmed through ftir test) no crack observed on returned samples. All the complaints occurred before use (pre-test).
 
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Brand NameBD SYRINGE 10CC S/T WOS STERILE WATER BNS
Type of DeviceSYRINGE
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
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8375314
MDR Text Key137672400
Report Number1213809-2019-00289
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeMY
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/27/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number304086
Device Lot NumberSEE H.10
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/27/2019 Patient Sequence Number: 1
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