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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿

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BECTON DICKINSON MEDICAL SYSTEMS BD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿ Back to Search Results
Catalog Number 309658
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem No Code Available (3191)
Event Date 09/14/2016
Event Type  Injury  
Manufacturer Narrative
The date of event is unknown. The date received by the manufacturer is used. The medical device expiration date is unknown as the lot number is unknown. (b)(4). (b)(6). The device manufacture date is unknown as the lot number is unknown. Device evaluation: results- a sample is not available for investigation. A review of the device history record cannot be completed as the lot number was not provided for this incident. Conclusion- without a sample, an absolute root cause for this incident cannot be determined. If further information is received after this time, a supplemental report will be filed.
 
Event Description
It was reported that the clinic nurse was giving an injection when the needle (device unknown) dislodged from the suspect device and the patient did not received his entire dose of medication. The physician was notified and prescribed an oral supplementation for the patient to take until his next injection.
 
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Brand NameBD PLASTIPAK¿ 3ML SYRINGE LUER-LOK¿
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 Key6008691
MDR Text Key56765470
Report Number1213809-2016-00030
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K110771
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number309658
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 Received09/14/2016
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: 10/06/2016 Patient Sequence Number: 1
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