MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Catalog Number 928858

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem Hypoglycemia (1912)

Event Date 09/24/2019

Event Type  Injury  

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9063755, medical device expiration date: 2024-03-31, device manufacture date: 2019-03-04.Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no: 928858, batch no: 9063755, unknown.It was reported that during use of the syringe 0.3ml 31ga 8mm 10bag 500 pl/wg the scale markings at the top of the syringe are thicker and make it difficult to read and have the correct dose.Dex com device alarm went off with a glucose reading of less than 40.For the past 6 weeks mother of the child wakes up during the night to feed daughter sugar because of being consistently low.The following information was provided by the initial reporter: it was reported that the customer is finding a good amount with the scale markings thicker toward the top of syringe between 1/2unit marker and 1 1/2unit marker.Mom stated her child (daughter) using the syringe has been getting consistent low readings during the night for the past 6 weeks.09/24/2019 daughters dex com device alarm went off with a glucose reading of less than 40.For the past 6 weeks mom wakes up during the night to feed daughter sugar because of being consistently low.Mom feel the scales being thicker toward the top of the syringe is throwing the accuracy of the dose off.

Event Description

Material no: 928858 ; batch no: 9063755, unknown.It was reported that during use of the syringe 0.3ml 31ga 8mm 10bag 500 pl/wg the scale markings at the top of the syringe are thicker and make it difficult to read and have the correct dose.Dex com device alarm went off with a glucose reading of less than 40.For the past 6 weeks mother of the child wakes up during the night to feed daughter sugar because of being consistently low.The following information was provided by the initial reporter: it was reported that the customer is finding a good amount with the scale markings thicker toward the top of syringe between 1/2unit marker and 1 1/2unit marker.Mom stated her child (daughter) using the syringe has been getting consistent low readings during the night for the past 6 weeks.(b)(6) 2019 daughters dex com device alarm went off with a glucose reading of less than 40.For the past 6 weeks mom wakes up during the night to feed daughter sugar because of being consistently low.Mom feel the scales being thicker toward the top of the syringe is throwing the accuracy of the dose off.

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 #9063755.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There was one (1) notification (b)(4) noted for damaged tips.As no samples and/or photo(s) were 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.

• Brand Name: SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9261707
• MDR Text Key: 167786652
• Report Number: 1920898-2019-01224
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 928858
• Device Lot Number: SEE H.10
• Initial Date Manufacturer Received: 09/25/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 09/25/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention