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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; INSULIN SYRINGE WITH NEEDLE

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE; INSULIN SYRINGE WITH NEEDLE Back to Search Results
Catalog Number 324912
Device Problems Material Separation (1562); Sticking (1597)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/19/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: 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
It was reported the needle became stuck in the vial and became separated from the shield when using a bd insulin syringe with the bd ultra-fine¿ needle.There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7177600.All inspections were performed per the applicable operations qc specifications.Syringe assembly ¿ there was one (1) batch of material# 700003982 (syringe 1.0ml asm 31ga 6mm sm700177 sc) that went into finished batch# 7177600.Batch# 7177600 date(s) of manufacture: 12aug2017 thru 17aug2017 machine(s) manufactured on: jl, jm, jn, jo pils ¿ there was one (1) batch of material# 700003981 (barrel 1.0ml shd 31ga 6mm sm700177) that went into finished batch# 7177600.Batch# 7177600 date(s) of manufacture: 12aug2017 thru 17aug2017 machine(s) manufactured on: fk there was one (1) notification [200704092] noted for insufficient adhesive.There were six (6) notifications [200704655, 200704654, 200704144, 200704115,200704653, 200704803] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 2nd related complaint for needle separates in vial and the 1st related complaint for needle hub separates on lot # 7177600.Based on the samples / photo(s) received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.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.If samples are received in the future the complaint will be reopened for further investigation.
 
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Brand Name
BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
Type of Device
INSULIN SYRINGE WITH NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7512544
MDR Text Key108241169
Report Number1920898-2018-00315
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 05/21/2018
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 Number324912
Device Lot Number7177600
Initial Date Manufacturer Received 04/19/2018
Initial Date FDA Received05/14/2018
Supplement Dates Manufacturer Received04/19/2018
Supplement Dates FDA Received05/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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