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

Catalog Number 320310

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/08/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported prior to use the nurse drew up a bd¿ insulin syringe with ultra-fine¿ needle syringe with insulin and adjusted the needle to position a better flow and the needle broke off from the syringe.No serious injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: customer returned five 1cc, 12.7mm, 29g syringes in an open poly bag from lot # 6291922.Customer states that the needle broke off from the syringe.All returned syringes were examined and one sample exhibited a detached cannula.The sample was examined under the microscope and exhibited adhesive runoff onto the hub with little adhesive inside the hub.All remaining samples also exhibited some adhesive runoff onto the hub.A review of the device history record was completed for batch # 6291922.All inspections and challenges were performed per the applicable operations qc specifications.Probable root cause determined to be misalignment during application of adhesive on the needle lines.When this occurs, adhesive runover onto the hub or possible the cannula may occur.Additionally, adhesive may be inaccurately applied to the rubberized pull wheel on the line, which can additionally transfer adhesive to the cannula during routine use.On 30jan2018, (b)(4) received five 1.Ml, 12.7mm, 29g syringes in an opened polybag from batch# 6291922.All samples were decontaminated per hstr-17 prior to being evaluated.Investigation conclusion: based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (adhesive runoff onto hub).Upon evaluation by qe ah, similar findings to those found during initial investigation at bd (b)(4) were noted.Probable root cause for cannula separate sample is likely due to the misalignment of the adhesive nozzle during production of this batch.When this occurs, insufficient adhesive is applied to the barrel core, where the adhesive is meant to affix the cannula and be cured during manufacturing.This can increase the chances of cannula separating from the remainder of the syringe either during transport or during initial use of the device.Capa (b)(4) was initiated by the (b)(4) plant to address 1ml product complaints.

• Brand Name: BD¿ INSULIN SYRINGE WITH ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7157760
• MDR Text Key: 96224704
• Report Number: 1920898-2017-00425
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 11/30/2021
• Device Catalogue Number: 320310
• Device Lot Number: 6291922
• Date Manufacturer Received: 12/08/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other