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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK¿ DISPOSABLE SYRINGE Back to Search Results
Catalog Number 309628
Device Problem Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/24/2018
Event Type  malfunction  
Manufacturer Narrative
(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 rubber plunger of the bd luer-lok¿ disposable syringe, detaches from the white plunger rod. Staff reports being able to sometimes push the plunger back in to start over. Found during use. No reports of serious injury or medical intervention noted.
 
Event Description
It was reported that rubber plunger of the bd luer-lok¿ disposable syringe, detaches from the white plunger rod. Staff reports being able to sometimes push the plunger back in to start over. Found during use. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
Investigation summary: one 1ml ll syringe inside an opened package was received taped to piece of paper. The sample was confirmed to be from batch #7235566 (p/n 309628). It was evaluated. No visual defects were observed. The plunger had the stopper attached and was at the bottom out position. The plunger was pulled back until the break out occurred ¿ the stopper remained attached to the plunger rod. The plunger was exercised to the 1ml marking and back down to zero. No defects were found in the sample received. No root cause or corrective actions can be determined as no defects were confirmed. Also, this is the 1st related complaint for stopper seperation from plunger on the provided lot number 7235566. Moreoever, 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. Investigation conclusion: the reported defect was not identified in the samples received. Unable to determine a root cause.
 
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Brand NameBD LUER-LOK¿ DISPOSABLE SYRINGE
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
8015652845
MDR Report Key7634523
MDR Text Key112437659
Report Number1213809-2018-00369
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/24/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309628
Device Lot Number7235566
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/08/2017
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: 06/25/2018 Patient Sequence Number: 1
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