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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD CARIBE LTD. BD¿ LONG LENGTH SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE
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BD CARIBE LTD. BD¿ LONG LENGTH SPINAL NEEDLE; ANESTHESIA CONDUCTION NEEDLE Back to Search Results
Model Number 408360
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/29/2022
Event Type  malfunction  
Event Description
It was reported that the bd¿ long length spinal needle experienced inconsistent labelling information.The following information was provided by the initial reporter: differing expiry date stated on the certificate of compliance and the packaging.
 
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary no samples or photos were received from the customer for this investigation.Based on the investigation bd juncos was able to confirm the customer¿s failure mode.However, the product is properly labeled with the correct date.This complaint is systematic, the most probable cause is operator error.A review of the device history record was performed, and no quality issues were found during production.
 
Event Description
It was reported that the bd¿ long length spinal needle experienced inconsistent labelling information.The following information was provided by the initial reporter: differing expiry date stated on the certificate of compliance and the packaging.
 
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Brand Name
BD¿ LONG LENGTH SPINAL NEEDLE
Type of Device
ANESTHESIA CONDUCTION NEEDLE
Manufacturer (Section D)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer (Section G)
BD CARIBE LTD.
road 31
k.m. 24.3
juncos
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15277750
MDR Text Key298507058
Report Number2618282-2022-00048
Device Sequence Number1
Product Code BSP
UDI-Device Identifier30382904083602
UDI-Public30382904083602
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K210978
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number408360
Device Catalogue Number408360
Device Lot Number1182339
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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