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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER-LOK WITH NEEDLE PISTON SYRINGE

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BECTON DICKINSON MEDICAL SYSTEMS BD¿ LUER-LOK WITH NEEDLE PISTON SYRINGE Back to Search Results
Catalog Number 309571
Device Problems Entrapment of Device (1212); Retraction Problem (1536)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/22/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. 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: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. Dhr review for batch 7235628 (p/n 305270): manufacturing dates: 09/21/2017 to 09/23/2017. Batch quantity was (b)(4). All visual inspections were performed as per requirement with no quality notifications related to the complaint defect. Batch 7235628 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment. Root cause description: root cause and capa not required as no defects were confirmed.
 
Event Description
It was reported that during use a bd integra¿ syringe with detachable needle malfunctioned as the needle retraction failed "and remains inside the patient. The patient received an injection on (b)(6) 2018 at the (b)(6) health center and was instructed to go to the emergency room. The healthcare staff stated the emergency room referred the patient to an orthopedic surgeon to get the needle removed. The healthcare staff does not know if/what treatment the patient received at the emergency room. No further information is available in regards to what medical intervention was needed.
 
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Brand NameBD¿ LUER-LOK WITH NEEDLE
Type of DevicePISTON SYRINGE
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 Key7558723
MDR Text Key111301526
Report Number1213809-2018-00351
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2022
Device Catalogue Number309571
Device Lot Number7093501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/03/2017
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: 05/31/2018 Patient Sequence Number: 1
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