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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD¿ NANO ULTRA-FINE PEN NEEDLE; AUTOINJECTOR NEEDLE
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BECTON DICKINSON AND CO. BD¿ NANO ULTRA-FINE PEN NEEDLE; AUTOINJECTOR NEEDLE Back to Search Results
Catalog Number 320883
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bruise/Contusion (1754); Blood Loss (2597)
Event Date 12/11/2018
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown.Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
"t" was reported that the consumer experienced bruising and bleeding after injecting when using bd¿ nano ultra-fine pen needles.The consumer addressed this issue with her doctor during her next visit.
 
Event Description
It was reported that the consumer experienced bruising and bleeding after injecting when using bd¿ nano ultra-fine pen needles.The consumer addressed this issue with her doctor during her next visit.
 
Manufacturer Narrative
Investigation summary: customer returned ( 5 ) 4mm, 32g sealed bd pen needles.Customer reports bruising and bleeding after she injects.All 5 returned pen needles were tested for point geometry, outer diameter and lube coverage.The following was observed (specs: outer diameter for 32g: 0.0090¿- 0.0095¿): data: point (pe/npe) outer diameter (in) lube sample 1: good/good.0.0090; good.Sample 2: good/good.0.0090; good.Sample 3: good/good.0.0091; good.Sample 4: good/good.0.0091; good.Sample 5: good/good.0.0090; good.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.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.Based on the above, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that the consumer experienced bruising and bleeding after injecting when using bd¿ nano ultra-fine pen needles.The consumer addressed this issue with her doctor during her next visit.
 
Manufacturer Narrative
Correction: describe event or problem: it was reported that the consumer experienced bruising and bleeding after injecting when using bd¿ nano ultra-fine pen needles.The consumer addressed this issue with her doctor during her next visit.In section h.10 of the previously submitted mdr, sections d.1 was incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: medical device expiration date.
 
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Brand Name
BD¿ NANO ULTRA-FINE PEN NEEDLE
Type of Device
AUTOINJECTOR NEEDLE
Manufacturer (Section D)
BECTON DICKINSON AND CO.
pottery road
dun laoghaire co
MDR Report Key8204215
MDR Text Key131662253
Report Number9616656-2018-00347
Device Sequence Number1
Product Code FMI
UDI-Device Identifier10885403897511
UDI-Public10885403897511
Combination Product (y/n)N
PMA/PMN Number
K131358
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup,Followup
Report Date 01/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number320883
Device Lot Number8010989
Initial Date Manufacturer Received 12/11/2018
Initial Date FDA Received12/28/2018
Supplement Dates Manufacturer Received12/11/2018
12/11/2018
Supplement Dates FDA Received01/09/2019
01/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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