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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE AND NEEDLE Back to Search Results
Catalog Number 305271
Device Problems Detachment Of Device Component (1104); Retraction Problem (1536)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2017
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: sample evaluation: one loose 3ml integra assembled syringe with needle and twelve 3ml integra packaged syringes with needle were received by bd (b)(4) and confirmed to be from batch #4274640 (p/n305271). The samples were visually evaluated. One loose syringe had needle retracted and no defects were observed. Twelve packaged syringes ¿ the syringes were all activated inside the sealed packages. Two of them had loosened hubs which allowed for the needle and the spring to come out of the barrel and into the packages. Premature activation is a rejectable condition. Dhr review for batch 4274640 (p/n 305271): manufacturing dates: 10/27/2014 to 10/29/2014. Batch quantity was (b)(4). All visual inspections were performed as per requirement with no quality notifications related to the complaint defect. Batch 4274640 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends. Based on the sample evaluation: confirmed: bd (b)(4) was able to confirm the customer's indicated failure. Investigation conclusion: root cause undetermined.
 
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 after use, a bd integra¿ syringe with detachable needles malfunctioned as the safety device failed to retract. There was no report of injury or medical intervention.
 
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Brand NameBD INTEGRA¿ SYRINGE WITH 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 Key7165043
MDR Text Key264611213
Report Number1213809-2017-00412
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K011103
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 03/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2019
Device Catalogue Number305271
Device Lot Number4274640
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 Received12/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2014
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: 01/04/2018 Patient Sequence Number: 1
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