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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE; PISTON SYRINGE Back to Search Results
Catalog Number 328418
Device Problem Contamination (1120)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/16/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.Investigation summary: customer returned a photo of a cannula.Customer states that he noticed what looked like an actual piece of tissue adhering near the tip of the needle itself.The attached photo was examined and exhibited a piece of material on the cannula shaft.However, it is difficult to determine the identity of the observed fm on the cannula without the actual sample.A review of the device history record was completed for batch# 7353795.All inspections were performed per the applicable operations qc specifications.There were five (5) notifications [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion based on the samples / photo(s) received the investigation concluded: confirmed: bd was 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.Root cause description: root cause cannot be determined at this time as the identity of the fm observed on the cannula cannot be determined without the actual sample.Rationale: based on the investigation, no additional investigation and no capa is required at this time.
 
Event Description
It was reported that before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.
 
Manufacturer Narrative
Awareness date corrected from: 16-jul-2018 corrected to: 15-jul-2018.Date received by manufacturer: 7/15/2018.
 
Event Description
It was reported that before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.
 
Event Description
It was reported that before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.
 
Manufacturer Narrative
Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other, d.8.Device single use?: no, h.3.Device returned to manufacture: no.
 
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Brand Name
BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7752968
MDR Text Key116250086
Report Number1920898-2018-00576
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00382908418034
UDI-Public00382908418034
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,Followup
Report Date 09/28/2018
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 Expiration Date12/31/2022
Device Catalogue Number328418
Device Lot Number7353795
Initial Date Manufacturer Received 07/16/2018
Initial Date FDA Received08/06/2018
Supplement Dates Manufacturer Received07/16/2018
07/15/2018
Supplement Dates FDA Received09/19/2018
09/28/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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