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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE
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BECTON DICKINSON DE MEXICO BD PRECISIONGLIDE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE Back to Search Results
Catalog Number 302358
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/12/2023
Event Type  malfunction  
Event Description
It was reported that 5 bd precisionglide¿ needles had open seals on their unit packaging.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter, translated from spanish: " rejection in inspection by attributes: deformed material.Needle guard with holes, tears, dents, or open seal.Needle protruding or embedded in the needle shield.Excess adhesive on the base or hub.Open primary packaging seal (there are 5 pieces as evidence).".
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 13-sep-2023.H.6.Investigation summary: two hundred seventy samples and photos received by our quality team for investigation.Through visual evaluation, double needle, bent needle, epoxy on the cannula, opened packaging seal, and damaged shield are observed.A device history review was performed for reported lot 2339643, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Based on the teams investigation, possible root cause for bent needle, double needle, and epoxy on cannula are associated with jamming in the needle assembly process.Possible root cause for packaging integrity is associated with failure of roller positioning.Possible root cause for damaged shield is associated with the shield-hub assembly process.Manufacturing personnel have been notified of this incident to increase awareness of this matter.Procedure and maintenance monthly plan will be updated.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported that 5 bd precisionglide¿ needles had open seals on their unit packaging.This complaint was created to capture the 1st of 3 related incidents.The following information was provided by the initial reporter, translated from spanish: " rejection in inspection by attributes: deformed material.Needle guard with holes, tears, dents, or open seal.Needle protruding or embedded in the needle shield.Excess adhesive on the base or hub.Open primary packaging seal (there are 5 pieces as evidence).".
 
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Brand Name
BD PRECISIONGLIDE¿ NEEDLE
Type of Device
HYPODERMIC SINGLE LUMEN NEEDLE
Manufacturer (Section D)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer (Section G)
BECTON DICKINSON DE MEXICO
autopista
55 59 99 8400, k.m. 37.5
cuautitlan izcalli
Manufacturer Contact
jennifer suh
9450 south state street
sandy, UT 84070
8448235433
MDR Report Key17450523
MDR Text Key320339826
Report Number9614033-2023-00069
Device Sequence Number1
Product Code FMI
Combination Product (y/n)N
Reporter Country CodeMX
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/03/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number302358
Device Lot Number2339643
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2023
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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