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

Catalog Number 328468

Device Problems Moisture Damage (1405); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 before use of the bd insulin syringe with the bd ultra-fine¿ needle there was an issue with foreign matter/hub separation the customer states ¿there was moisture inside of the syringe and also the needle hub separated from the syringe that stayed inside of the cap.Customer does not re-use syringes.¿ there was no report of injury or further medical intervention.

Manufacturer Narrative

Investigation summary: two investigations were carried out.First investigation summary: customer returned (4) 1/2cc, 8mm, 31g syringes in an open poly bag from lot # 7290606.Customer states that there was moisture inside the syringe and the needle hub separated.Two out of 4 syringes were returned with the hub-needle/shield assembly separated from the barrel.No damage to the barrels was observed.One of the syringe remaining syringes exhibited visible liquid inside the barrel.A small portion of this material was removed from the barrel and prepared for ftir spectral analysis.The spectral analysis suggests that this material has components similar to those of silicone.Silicone is an inert, non-toxic medical substance used as a lubricant for disposable hypodermic products.It is an integral part of the syringe, enabling it to perform as required in various clinical applications and does not present a safety or efficacy issue nor does it impact product function.The silicone application process is designed to provide an even distribution of silicone on the interior of the syringe barrel.When the plunger is fully depressed, the silicone gets distributed along the barrel roof and walls, ensuring a lubricated surface for the plunger to move against.Silicone has been in use in this application for over 20 years, with estimated distribution well in excess of 25 billion units.No reports are known of adverse clinical effects associated with these products and unintentional delivery of silicone fluid lubricant.Sample will be forwarded to manufacturing (holdrege) on (b)(6)2018 for further review.Second investigation summary: on (b)(6)2018 , holdrege received four (4) 0.5ml, 8mm, 31g syringes in opened polybag from batch # 7290606.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.Additionally, minor damage to the barrel tips and the hub cores of the separated hub assemblies was noted through visualization of the returned samples.No silicone pooling was noted in the sample identified at bd franklin lakes, as it was received.Probable root cause likely to be a misalignment during assembly on the metro for this batch.When this type of event occurs, damage to the hub core and/or barrel tip can cause impermanent seating of the hub assembly to the remainder of the syringe.This can lead to hub separates either during transit or initial activation by the consumer.Capa 97451 was initiated by the holdrege plant to address needle hub separates and their associated root cause(s).Batch# 7290606 was manufactured prior to full implementation corrective/preventive actions associated with this capa.A review of the device history record was completed for batch# 7290606.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200722097] noted for cracked hubs.There were three (3) notifications [200722182, 200720376, 200722348] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for foreign matter inside syringe and the 1st related complaint for needle hub separates on lot # 7290606.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates and excess silicone).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.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7443278
• MDR Text Key: 106038213
• Report Number: 1920898-2018-00278
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• 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: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328468
• Device Lot Number: 7290606
• Date Manufacturer Received: 04/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other