MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Model Number 328468

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hyperglycemia (1905)

Event Date 06/16/2020

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 a 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 dimension and hyperglycemia on lot # 9322380.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, dimension and hyperglycemia) was captured and addressed appropriately.Investigation summary: customer returned five (5) loose 31gx8mm, 0.5ml bd insulin syringes.Consumer reported getting higher glucose readings due to the change of the needle size.All five returned syringes were examined, then tested for cannula length and outer diameter.The following was observed (specs: outer diameter for 31g cannula: 0.0100¿- 0.0105¿): data: cannula length outer diameter (in.) sample 1 good 0.0101.Sample 2 good 0.0101.Sample 3 good 0.0102.Sample 4 good 0.0102.Sample 5 good 0.0102.All five syringes tested within specification.Next, all five syringes were tested for flow: all five syringes were able to draw and expel properly.No evidence of manufacturing defect was observed.Since no defects were observed the alleged issues could not be confirmed.A review of the device history record was completed for batch# 9322380.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200862180] 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 high glucose readings were found after changing the needle size of the bd insulin syringe with the bd ultra-fine¿ needle.This was discovered after use.The following information was provided by the initial reporter: material no: 328468 batch no: 9322380.It was reported getting higher glucose readings due to the change of the needle size.Verbatim: consumer reported claims switched to this size 3 weeks ago and now getting higher glucose test.Was using the 12.7mm.Has not seen doctor advised consumer to do so.Glucose values with 12.7 avg 140-160 with 8mm getting 240.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• Type of Device: PISTON 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: 10237763
• MDR Text Key: 199256748
• Report Number: 1920898-2020-00793
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328468
• Device Catalogue Number: 328468
• Device Lot Number: 9322380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• 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