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

Catalog Number 328821

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.No lot # provided.Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that during use, a bd ultra-fine¿ insulin syringe malfunctioned as the needle separated from the syringe.There was no report of injury or medical intervention needed.

Manufacturer Narrative

Investigation summary: customer returned a photo of a 1cc syringe.Customer states that the catheter split.The photo was examined and exhibited the cannula separated from the syringe and stuck in the vial.Capa (b)(4) has been opened to address this issue for 1ml syringes.Unable to perform complaint lot history check due to unknown lot number.Investigation based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (cannula separates).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.Root cause description: 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.Capa (b)(4) has been opened to address this issue for 1ml syringes.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7190559
• MDR Text Key: 97882482
• Report Number: 1920898-2017-00449
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328821
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other