MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES W/ BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Catalog Number 328289

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd insulin syringes w/ bd ultra-fine¿ needle plunger was difficult to move.This was discovered during use.The following information was provided by the initial reporter: material no: 328289, batch no: 8344603.It was reported by the consumer that after drawing up insulin, the plunger would not move.Not able to provide product information because consumer is at work.Stated: was able to draw insulin but could not dispense it.Plunger rod would not move.Blood sugar levels affected.Could not get medication.Only had 1 syringe at work.Will take insulin when he goes home.Does not plan on seeing a doctor.Incident date: (b)(6) 2019.Additional info provided by consumer states: reason for call: syringe malfunctioned.Drew insulin, but the plunge got stuck -- and was immovable -- when i tried to dispense the insulin into the site.I tried 5 different sites, and the syringe would not work, no matter how much force i applied.

Manufacturer Narrative

H.6.Investigation summary: customer returned (1) loose 1cc, 8mm syringe filled with approximately 10 units of a cloudy liquid in the barrel.Customer states that after drawing up insulin, the plunger would not move.The returned syringe was tested and the plunger was able to be exercised in the barrel without any observed defects.A complaint history check was performed and this is the 1st related complaint for plunger rod unable to move on lot # 8344603.A review of the device history record was completed for batch# 8344603.All inspections were performed per the applicable operations qc specifications.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.

Event Description

It was reported that bd insulin syringes w/ bd ultra-fine¿ needle plunger was difficult to move.This was discovered during use.The following information was provided by the initial reporter: material no: 328289 batch no: 8344603.It was reported by the consumer that after drawing up insulin, the plunger would not move.Not able to provide product information because consumer is at work.Stated: was able to draw insulin but could not dispense it.Plunger rod would not move.Blood sugar levels affected.Could not get medication.Only had 1 syringe at work.Will take insulin when he goes home.Does not plan on seeing a doctor.Incident date: (b)(6) 2019.Additional info provided by consumer states: reason for call: syringe malfunctioned.Drew insulin, but the plunge got stuck -- and was immovable -- when i tried to dispense the insulin into the site.I tried 5 different sites, and the syringe would not work, no matter how much force i applied.

• Brand Name: BD INSULIN SYRINGES W/ BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8992212
• MDR Text Key: 157410089
• Report Number: 1920898-2019-00962
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282890
• UDI-Public: 00382903282890
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

1 Device 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 Expiration Date: 12/31/2023
• Device Catalogue Number: 328289
• Device Lot Number: 8344603
• Initial Date Manufacturer Received: 08/27/2019
• Initial Date FDA Received: 09/11/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No