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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.
 
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Brand NameRELION® INSULIN SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer (Section G)
BD MEDICAL - DIABETES CARE
1329 west highway 6
holdrege NE 68949
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8805167
MDR Text Key151554912
Report Number1920898-2019-00685
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K170386
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation
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
Device Catalogue Number328506
Device Lot Number8190574
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/17/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/18/2019 Patient Sequence Number: 1
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