MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP

Catalog Number 324900

Device Problems Volume Accuracy Problem (1675); Failure to Deliver (2338)

Patient Problem Hypoglycemia (1912)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: level b investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for scale misaligned and hypoglycemia on lot # 9343309.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, scale misaligned, hypoglycemia) was captured and addressed investigation summary: customer returned (2) loose 3/10cc, 6mm syringes.Customer states that the scale mark was inaccurate so that caused hypoglycemia.Both returned syringes were tested using the plug gauge and all scale marking placements fell within specifications for both returned syringes.A review of the device history record was completed for batch # 9343309.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that did not pertain to the complaint.Investigation conclusion: based on the samples and/or photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.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.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that syringe 0.3ml 31ga 6mm 10bag 500 ap had scale marking issues.Hypoglycemia occurred because of this.This was discovered after use.The following information was provided by the initial reporter: inaccurate scale mark.Scale mark was inaccurate so that caused hypoglycemia.

• Brand Name: SYRINGE 0.3ML 31GA 6MM 10BAG 500 AP
• Type of Device: 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 Key: 10480714
• MDR Text Key: 206510918
• Report Number: 1920898-2020-01151
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324900
• Device Lot Number: 9343309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other