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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE; INSULIN SYRINGE AND NEEDLE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE; INSULIN SYRINGE AND NEEDLE Back to Search Results
Catalog Number 320468
Device Problems Filling Problem (1233); No Flow (2991)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/01/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 that before use of the bd ultra-fine ii¿ (short) self-contained insulin syringe, the syringe would not press out insulin.Additionally, it was reported that one syringe would not draw up insulin or air.There was no report of exposure, injury, or medical intervention noted.
 
Event Description
It was reported that before use of the bd ultra-fine ii (short) self-contained insulin syringe, the syringe would not press out insulin.Additionally, it was reported that one syringe would not draw up insulin or air.There was no report of exposure, injury, or medical intervention noted.
 
Manufacturer Narrative
Customer returned (1) 1/2cc, 8mm, 30g syringe in an open poly bag from lot # 7178868.Customer states that they tried to use the syringe and nothing would come out or in not even air and found 1 syringe that would not press out insulin.The returned syringe was tested and the plunger rod was able to move through the barrel, however, the syringe was not able to draw properly.The sample was then wired and the wire was not able to pass through the cannula.This indicates that there is an adhesive clog in the cannula.A review of the device history record was completed for batch# 7178868.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications [(b)(4)] noted that did not pertain to the complaint.Based on the samples/photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (plunger rod difficult to move).Root cause cannot be determined at this time as the issue is unconfirmed.
 
Manufacturer Narrative
Correction: 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: event attributed to: other.Device single use?: no.Device returned to manufacture: no.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# 7178868.All inspections and challenges were performed per the applicable operations qc specifications.There were four (4) notifications (b)(4) noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger rod difficult to move on lot # 7178868 and the 2nd related complaint for unable to perform function on lot # 7178868.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.If samples are received in the future the complaint will be reopened for further investigation.
 
Event Description
It was reported that before use of the bd ultra-fine ii¿ (short) self-contained insulin syringe, the syringe would not press out insulin.Additionally, it was reported that one syringe would not draw up insulin or air.There was no report of exposure, injury, or medical intervention noted.
 
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Brand Name
BD ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE
Type of Device
INSULIN SYRINGE AND NEEDLE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7802039
MDR Text Key117849486
Report Number1920898-2018-00641
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,other
Type of Report Initial,Followup,Followup
Report Date 10/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/31/2022
Device Catalogue Number320468
Device Lot Number7178868
Was Device Available for Evaluation? No
Date Manufacturer Received08/01/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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