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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP VETERINARY SYRINGE WITH NEEDLE HYPODERMIC SYRINGE AND NEEDLE

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BECTON DICKINSON MEDICAL SYSTEMS BD¿ SLIP TIP VETERINARY SYRINGE WITH NEEDLE HYPODERMIC SYRINGE AND NEEDLE Back to Search Results
Catalog Number 305664
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/13/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. 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 the unspecified bd¿ slip tip veterinary syringe with needle separated from the hub with just the slightest pressure. Multiple reports of the same occurrence happening before or during use. Needles slipped off hubs during reconstitution of vaccinations before patient use, and during injections of medication administration. No reports of serious injury or medical intervention noted.
 
Manufacturer Narrative
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. Dhr review for batch 7266716 (p/n 305664). Manufacturing dates: 10/26/2017 to 10/29/2017. Batch quantity was (b)(4). Assembly records were reviewed as part of this dhr review. All visual inspections were performed as per requirement with no quality notifications related to the complaint defect. Batch 7266716 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment. Unconfirmed: bd was not able to confirm the customer¿s indicated failure investigation conclusion: no root cause can be determined as no samples were received.
 
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Brand NameBD¿ SLIP TIP VETERINARY SYRINGE WITH NEEDLE
Type of DeviceHYPODERMIC SYRINGE 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 Key7375237
MDR Text Key103804938
Report Number1213809-2018-00208
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N/A
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
Report Date 04/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305664
Device Lot Number7266716
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 Received03/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/04/2017
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: 03/27/2018 Patient Sequence Number: 1
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