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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE; PISTON SYRINGE
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BD MEDICAL - DIABETES CARE RELION INSULIN SYRINGE; PISTON SYRINGE Back to Search Results
Catalog Number 328506
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Bruise/Contusion (1754); Erythema (1840); Itching Sensation (1943); Reaction (2414)
Event Date 06/26/2019
Event Type  Injury  
Manufacturer Narrative
Device expiration date: n/a.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# 8190574.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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 description: 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 itchy skin and red marks occurred after use with a relion® insulin syringe.The following information was provided by the initial reporter, relion consumer stated: after injection in both her left and right thigh, she noticed "red streaks" that later became "warm" to the touch and "itchy".It happened on (b)(6) 2019 and (b)(6) 2019.8 syringes were used between these two dates before doctors visit.Stated: she takes 5 injections per day.Stated: went to see her primary doctor on (b)(6) 2019 who suggested she use a different brand.Stated: no medication or follow up visits necessary.Stated: she wipes the needle with a alcohol swab before use.Stated once the itching stops and redness goes away, a bruise is left behind.Lot: 8190574, item: 1ml, 8mm, 31g occurrence date: (b)(6) 2019".Complaint 2 of 2: date of occurrence (b)(6) 2019.
 
Event Description
It was reported that itchy skin and red marks occurred after use with a relion® insulin syringe.The following information was provided by the initial reporter, relion consumer stated: after injection in both her left and right thigh, she noticed "red streaks" that later became "warm" to the touch and "itchy".It happened on (b)(6) 2019 and (b)(6) 2019.8 syringes were used between these two dates before doctors visit.Stated: she takes 5 injections per day.Stated: went to see her primary doctor on (b)(6) 2019 who suggested she use a different brand.Stated: no medication or follow up visits necessary.Stated: she wipes the needle with a alcohol swab before use.Stated once the itching stops and redness goes away, a bruise is left behind.Lot: 8190574, item: 1ml, 8mm, 31g occurrence date: (b)(6) 2019" complaint 2 of 2: date of occurrence (b)(6) 2019.
 
Manufacturer Narrative
Investigation: customer returned (20) 1cc, 8mm, 31g relion syringes (10 loose, 10 in a sealed poly bag) from lot # 8190574.Customer states that after injection in both her left and right thigh, she noticed "red streaks" that later became "warm" to the touch and "itchy".All returned syringes were tested for point geometry, lube, and cannula od (specs: outer diameter for 31g: 0.0100¿-0.0105¿).All observations fall within specifications.A review of the device history record was completed for batch# 8190574.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure root cause cannot be determined at this time as the issue is unconfirmed.
 
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Brand Name
RELION INSULIN SYRINGE
Type of Device
PISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
MDR Report Key8805167
MDR Text Key151554912
Report Number1920898-2019-00685
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 08/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Catalogue Number328506
Device Lot Number8190574
Was Device Available for Evaluation? No
Date Manufacturer Received06/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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