MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; SYRINGE, ANTISTICK

Catalog Number 305934

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation summary: level b investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for difficult/unable to operate (not drawing) on lot # 9200478.This is an mds product, risks, hazards and harms are captured under the umbrella of risk management document (b)(4).Investigation summary: customer returned (1) 1/2ml, 8mm, 30g bd safetyglide insulin syringe from lot # 9200478.Customer states that it is unable to draw medication.The retuned syringe was tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 9200478.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained 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 1/2 ml bd safetyglide¿ insulin syringe with attached needle was unable to aspirate during use.The following information was provided by the initial reporter: unable to draw medicine.No deformation or damage in appearance.

• Brand Name: 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• 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: 10610378
• MDR Text Key: 209638810
• Report Number: 1920898-2020-01329
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K992734
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 305934
• Device Lot Number: 9200478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2019
• 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