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

Model Number 324909

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported during use the bd insulin syringe with the bd ultra-fine¿ needle experienced the cannula piercing through the shield (in polybag) and hub separating from the device.This event occurred 4 times.The following information was provided by the initial reporter: the customer stated "the needle part of the assembly stays stuck in the orange cover cap.So far there has been 4 syringes with this condition.".

Manufacturer Narrative

H.6.Investigation: customer returned (1) loose 3/10cc syringe with part of the shelf carton from lot # 9308363.Customer states that the needle part of the assembly stays stuck in the orange cover cap.The returned syringe was examined and was returned without the hub-needle/shield assembly.A review of the device history record was completed for batch# 9308363.All inspections and challenges were performed per the applicable operations qc specifications except as noted below.There were zero (0) notifications noted that pertained to the complaint.Process summary: automatic syringe assembly machine, which feeds 0.3ml, syringe components (barrel, stopper, plunger, needle assembly & cap) and assembles these components.This machine consists of a barrel cleaning dial, lubrication dial, plunger/stopper assembly dial, syringe assembly dial, and various inspections and transfer dials.Dhr, l2l dispatches, and logbook entries were looked at, nothing pertaining to this defect was found.Root cause for this defect cannot be determined.Capa#1630423 was initiated.H3 other text : see h.10.

Event Description

It was reported during use the bd insulin syringe with the bd ultra-fine¿ needle experienced the cannula piercing through the shield (in polybag) and hub separating from the device.This event occurred 4 times.The following information was provided by the initial reporter: the customer stated "the needle part of the assembly stays stuck in the orange cover cap.So far there has been 4 syringes with this condition.".

• 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
• MDR Report Key: 10486116
• MDR Text Key: 206337893
• Report Number: 1920898-2020-01161
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249091
• UDI-Public: 00382903249091
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 324909
• Device Catalogue Number: 324909
• Device Lot Number: 9308363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2020
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other