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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD RELION¿ INSULIN SYRINGE
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BD MEDICAL - DIABETES CARE BD RELION¿ INSULIN SYRINGE Back to Search Results
Catalog Number 328509
Device Problems Device Contamination with Chemical or Other Material (2944); Gas/Air Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/29/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7178872, device manufacture date: 08/29/2017, medical device expiration date: n/a.Medical device lot #: 7240981, device manufacture date: 10/25/2017, 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 that the relion¿ insulin syringe when used to push insulin back into vial to clear air bubbles, particles are seen going back into the vial making the insulin have a murky appearance.There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
Due to an it issue beginning on (b)(6) 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 manufacturer: yes.
 
Event Description
It was reported that the relion insulin syringe when used to push insulin back into vial to clear air bubbles, particles are seen going back into the vial making the insulin have a murky appearance.There was no report of exposure, serious injury or medical intervention.
 
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# 7178872.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 7240981.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [(b)(4)] noted for dry barrels.There were fourteen (14) notifications [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for adhesive splatter.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.Investigation conclusion: 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 the relion¿ insulin syringe when used to push insulin back into vial to clear air bubbles, particles are seen going back into the vial making the insulin have a murky appearance.There was no report of exposure, serious injury or medical intervention.
 
Manufacturer Narrative
H.6.Investigation summary: customer returned (12) loose 1/2cc, 8mm syringes.Customer states that when pushing insulin back into vial to clear air bubbles, particles are seen going back into the vial making the insulin have a murky appearance.All returned syringes were examined and no foreign matter was observed in the barrel or on the cannula of any of the samples.Also, no foreign matter came out of the cannula when fully depressing the plunger rod.A review of the device history record was completed for batch# 7178872.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch# 7240981.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200711384, 200712021] noted for dry barrels.There were fourteen (14) notifications [200713595, 200713508, 200713790, 200713884, 200711499, 200711351, 200711482, 200714307, 200713504, 200714278, 200711357, 200711724, 200689741, 200690372] noted that did not pertain to the complaint.There was one (1) notification [200716849] noted for adhesive splatter.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed.
 
Event Description
It was reported that the relion¿ insulin syringe when used to push insulin back into vial to clear air bubbles, particles are seen going back into the vial making the insulin have a murky appearance.There was no report of exposure, serious injury or medical intervention.
 
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Brand Name
BD RELION¿ INSULIN SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key7706909
MDR Text Key114806196
Report Number1920898-2018-00523
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Type of Report Initial,Followup,Followup,Followup
Report Date 08/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number328509
Device Lot NumberSEE H.10
Date Manufacturer Received06/29/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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