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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 328506
Device Problems Material Separation (1562); Suction Problem (2170)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/19/2018
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.A review of the device history record was completed for batch# 7318797.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted for an out of spec breakout and sustaining reading.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.
 
Event Description
It was reported that bd ultra-fine¿ insulin syringes were not drawing from 12 needles.It was also reported that during one of the aspirations the rubber plunger separated from the rod.There was no report of exposure, serious injury or medical intervention.
 
Event Description
It was reported that bd ultra-fine¿ insulin syringes were not drawing from 12 needles.It was also reported that during one of the aspirations the rubber plunger separated from the rod.There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Additional information: a sample was returned for evaluation.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: sex: male; event attributed to: other; device single use?: no; device returned to manufacture: no.Investigation summary: one 1ml 8mmx31g syringe received - stopper separates.Customer returned (1) loose 1cc relyion insulin syringe.Customer states the needle is not drawing insulin into the syringe , consumer also states that the rubber stopper disconnected from 1 syringe.The returned syringe was examined and when trying to draw the plunger back, the stopper separated from the plunger.A review of the device history record was completed for batch# 7318797.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200725039] noted for an out of spec breakout and sustaining reading.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for difficult/unable to operate and stopper separates on lot # 7318797.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure - bent cannula.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure - stopper separates.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.Sample was forwarded to manufacturing (holdrege) on 31 august 2018 for further review.On 11sep2018, holdrege received one (1) 1ml, 8mm, 31g syringe in opened polybag from batch # 7318797.All samples are decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.The returned sample was inspected and noted the hyper-bent cannula wedged in-between the shield and the syringe barrel shoulder.Additionally, the plunger rod was noted to disassembly from the stopper during attempted cycle testing.Upon removal of the cannula, the plunger rod was able to be exercised somewhat, appearing to have been stuck due to the disruption of airflow during movement.Probable root cause for the bent cannula is likely to be a misalignment during shielding on the pils (point inspect lube shield) equipment.When this type of event occurs, these could be an increased risk of bending the cannula to such the degree which is observed within the returned sample.Additionally, once the cannula is bent, the airflow through the cannula could be obstructed in such a way which would make the plunger rod/stopper assembly appear to be immovable, resulting, potentially, in the apparent separation of the stopper from the plunger rod.As the plunger rod was able to be moved once this obstruction was cleared, no defect is noted at this time.Capa (b)(4) was initiated by the holdrege plant to address 1ml customer complaints, specifically bent cannula and cannula separates, and their associated root cause(s).Batch# 7318797 was manufactured prior to corrective/preventive actions being implemented in association with this capa.
 
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Brand Name
BD ULTRA-FINE¿ INSULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7768155
MDR Text Key116867482
Report Number1920898-2018-00584
Device Sequence Number1
Product Code FMF
UDI-Device Identifier00681131311748
UDI-Public00681131311748
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 09/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number328506
Device Lot Number7318797
Was Device Available for Evaluation? No
Date Manufacturer Received07/19/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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