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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 10ML BD LUER-LOK¿ SYRINGE, 20GX1" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE SYRINGE AND NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS 10ML BD LUER-LOK¿ SYRINGE, 20GX1" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE SYRINGE AND NEEDLE Back to Search Results
Catalog Number 309644
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 07/27/2016
Event Type  Death  
Manufacturer Narrative
Date of event; date of death: the date of event is unknown therefore the date received by the manufacturer is used. The patient was reported to have passed away over a year ago. The medical device expiration date is unknown as the lot number is unknown. The device manufacture date is unknown as the lot number is unknown. Device evaluation: investigation summary - no samples were returned, or a lot number provided therefore the complaint could not be confirmed and the root cause is undetermined. In the verbatim it refers to a recall of the 10ml luer lok 20 gauge syringe of catalog number 309644. A product advisory was initiated for insecure stoppers. Refer to mss-14-485-sa. Potential issue for insecure stopper is leakage pass the stopper. For this issue, it is highly unlikely that the device in question lead to the patient¿s unfortunate death. The investigation concluded - bd was not able to duplicate or confirm the customer¿s indicated failure.
 
Event Description
A report was received from the customer with the following verbatim: "when performing effectiveness check on a supplier recall for the bd 10cc syringe luer lok 20gx1 detachable, a woman answered the phone. When i asked to speak with [the customer], she informed me he passed away over a year ago. " no additional information was received and the relationship of the suspect device to the patient death is unknown.
 
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Brand Name10ML BD LUER-LOK¿ SYRINGE, 20GX1" BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
Type of DeviceSYRINGE AND NEEDLE
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 Key5876454
MDR Text Key52110151
Report Number1213809-2016-00026
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial
Report Date 08/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number309644
Device Lot NumberUNKNOWN
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 Received07/27/2016
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

Patient Treatment Data
Date Received: 08/15/2016 Patient Sequence Number: 1
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