MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH 30G X 12.7 MM NEEDLE

Catalog Number 324824

Device Problem Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 09/12/2017

Event Type  Injury  

Manufacturer Narrative

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 that when medication injected from a 0.5 ml bd micro-fine¿ + insulin syringe with 30g x 12.7 mm needle particles of silicon from the syringe were also injected into the eyes of patients.Injury and medical intervention are unknown.

Manufacturer Narrative

Investigation summary: customer returned (90) 1/2cc, 12.7mm, 29g syringes in sealed poly bags with the shelf carton from lot # 6172630.Customer states that silicone from the syringe was injected into the eye of several patients.Thirty out of 90 returned syringes were examined visually and under the microscope and no foreign matter was observed on or in any of the samples.All of these samples were also tested and no material came out of the syringe when fully depressing the plunger rod.As per manufacturing, a review of the device history record was completed for batch# 6172630.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [(b)(4)] noted that did not pertain to the complaint based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure 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.Investigation conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: 0.5 ML BD MICRO-FINE¿ + INSULIN SYRINGE WITH 30G X 12.7 MM NEEDLE
• 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: 6947093
• MDR Text Key: 89286128
• Report Number: 1920898-2017-00233
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K941657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 324824
• Device Lot Number: 6172630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2016
• 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