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

Catalog Number 324917

Device Problems Detachment Of Device Component (1104); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 by a consumer that the needle separated in the protective cap prior to administering a growth hormone to his daughter using a bd insulin syringe with bd ultra-fine needle.In addition, the consumer also reported there was excess material on tip of the needle.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation results: severity: s1; occurrence: a complaint history check was performed and this is the 2nd related complaint for needle hub separates, the 1st related complaint for foreign matter and the 1st related complaint for dimension on lot # 6340587.Two investigations were carried out.First investigation summary: customer returned photos of 1/2cc syringe.These photos were examined and exhibited one syringe with the hub-needle/shield assembly separated from the barrel.No damage to the barrel was observed.Customer also returned (2) 1/2cc, 6mm, 31g syringes in an open poly bag from lot # 6340587.Customer states that the needle separated and got stuck in the orange protective cap (shield) and the other syringe informs that the tip of the needle has an excess of material, as it was flattened, the tip of the needle is larger than normal.Both returned syringes were tested and no hub assembly separated from the barrel.Both samples were examined under the microscope and one sample exhibited a small clear droplet of material on the cannula shaft.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis suggests that this material has components similar to those of silicone.No defects were observed on the cannula tip.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.Samples were forwarded to manufacturing (holdrege) on (b)(6) 2018 for further review.On (b)(6) 2018, holdrege received two (2) 0.5ml, 6mm, 31g syringes in opened polybag from batch # 6340587.All samples were decontaminated per hstr-17 prior to being evaluated.Second investigation summary: upon evaluation by qe ah, the customer's reported defects were not noted within the samples received for this customer complaint.No silicone pooling was noted within the samples themselves.Along one of the barrel exteriors, there was some damage noted from an unknown cause, however, this damage would not impair the operation of the device.A review of the device history record was completed for batch# 6340587.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications [(b)(4)] noted that did not pertain to the complaint.Based on the samples / photo(s) received bd was able to duplicate or confirm the customer¿s indicated failure (hub separates and excess silicone) bd was not able to duplicate or confirm the customer¿s indicated failure (dimension) possible root causes for excess silicone include: the first is that some associates do not degas the silicone after refilling the tanks.Second, the silicone volume on the pump is a parameter that is being adjusted, but is not understood and could be a potential kpiv.Possible root causes for hub separates issue include: - broken plunger lodged in between barrel and shield carriers may cause incomplete shield assemblies.Systems with plunger screw infeed¿s have a greater propensity for creating broken plungers versus machines with dial infeed¿s.- a misaligned laser sensor (raised shield) from its designated detecting position may result in sending defective parts with gate flash and/or raised needle assemblies to packaging as good product.- hub core damage (either from seating on racks or during assembly onto barrel), adhesive run-over causing excessive force required to remove shield, disassembling hub from the syringe.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.Capa # 56537 and situation analysis # (b)(4) have been opened to address the excess silicone issue.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7298080
• MDR Text Key: 101153859
• Report Number: 1920898-2018-00066
• 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: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Patient Family Member or Friend
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 324917
• Device Lot Number: 6340587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2018
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other