MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE INSULIN SYRINGE; PISTON SYRINGE

Model Number 928856

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problem Pain (1994)

Event Date 06/03/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: no samples 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# 9308772.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Occurrence: a complaint history check was performed and this is the 1st related complaint for needle hub loose on barrel, npi needle blunt, foreign matter (on needle tip) and npi needle pain on lot # 9308772.A review of risk management 150rmn-0001-16 revision 13 indicates that the potential risk of this specific reported incident (syringe, needle hub loose on barrel, npi needle blunt, foreign matter (on needle tip) and npi needle pain) was captured and addressed appropriately.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.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the needle hub was loose on the bd safetyglide¿ insulin syringe barrel during use, and foreign matter was found on the end of the needle tip.The following information was provided by the initial reporter: "needle hub is loose on barrel stated, having difficulty penetrating injection site stated, seeing something on the end of needle tip that's causing pain when taking injection stated, does not re-use and rotates injection site.".

• Brand Name: BD SAFETYGLIDE INSULIN SYRINGE
• 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: 10156021
• MDR Text Key: 199257784
• Report Number: 1920898-2020-00674
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: 9308772
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2019
• 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