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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML S/T 200 S/C; PISTON SYRINGE
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BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 10ML S/T 200 S/C; PISTON SYRINGE Back to Search Results
Catalog Number 303134
Device Problem Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/28/2019
Event Type  malfunction  
Manufacturer Narrative
Device evaluated by mfr: 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 during the preparation of an "intrathecal methotrexate", small bubbles were noticed behind the syringe 10ml s/t 200 s/c plunger, and while trying to draw up medication, leakage occurred from the seal between the plunger and barrel.The following information was provided by the initial reporter: "during preparation of an intrathecal methotrexate, the pharmacist noticed very small bubbles of drug behind the plunger.She was not drawing on the dose too hard that would potentially cause the seal between plunger and barrel to leak.She then tried again and the same thing happened.The next time she transferred the dose from another syringe to avoid the issue.The lot number is 6179873.No harm to the patient but potential exposure to staff to chemotherapy.".
 
Manufacturer Narrative
Correction: after additional review, this report is a duplicate report of mfr #1213809-2019-00434.This event has been over-reported.
 
Event Description
It was reported that during the preparation of an "intrathecal methotrexate", small bubbles were noticed behind the syringe 10ml s/t 200 s/c plunger, and while trying to draw up medication, leakage occurred from the seal between the plunger and barrel.The following information was provided by the initial reporter: "during preparation of an intrathecal methotrexate, the pharmacist noticed very small bubbles of drug behind the plunger.She was not drawing on the dose too hard that would potentially cause the seal between plunger and barrel to leak.She then tried again and the same thing happened.The next time she transferred the dose from another syringe to avoid the issue.The lot number is 6179873.No harm to the patient but potential exposure to staff to chemotherapy.".
 
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Brand Name
SYRINGE 10ML S/T 200 S/C
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL SYSTEMS
route 7 and grace way
canaan CT 06018
MDR Report Key8511163
MDR Text Key147196753
Report Number1213809-2019-00439
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Catalogue Number303134
Device Lot Number6179873
Date Manufacturer Received03/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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