MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE¿ INSULIN SYRINGE 31 G X 6 MM; INSLIN SYRINGE

Catalog Number 324918

Device Problem Insufficient Information (3190)

Patient Problems Erythema (1840); Itching Sensation (1943); No Code Available (3191)

Event Date 07/24/2017

Event Type  Injury  

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.(b)(4).

Event Description

It was reported the customer complained of papule, itching and redness at the injection site with a bd ultra-fine¿ insulin syringe 31 g x 6 mm.No medical interventions provided.

Manufacturer Narrative

Results: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 5201563.Investigation summary: customer returned photos of red marks on the body.No photos of the product in question were returned by the customer.Customer states that the use of the product promoted papule formation in the application site, moreover the region got reddish and it caused itching.As per manufacturing, there were zero (0) defects or notifications noted for any defects during the production of these batches.Also, no issues with sterility were noted on the reported lot number.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as none of the records from manufacturing indicate any issues with the product.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.Based on the above, no additional investigation and no capa is required at this time.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure as none of the records from manufacturing indicate any issues with the product.Without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE 31 G X 6 MM
• Type of Device: INSLIN 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: 6804714
• MDR Text Key: 83051848
• Report Number: 1920898-2017-00111
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 324918
• Device Lot Number: 5201563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• 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