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

Catalog Number 320468

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Glaucoma (1875)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The customer's address is unknown.(b)(6) usa has been used as a default.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that over the past 6-9 months, increased cases of glaucoma were seen with the use of the bd insulin syringe with the bd ultra-fine¿ needle and avasten.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation results: severity: s3; occurrence: unable to perform complaint lot history check due to unknown lot number.Unable to perform dhr check due to unknown lot number.No samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause cannot be determined at this time as the issue is unconfirmed.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.

• Brand Name: BD ULTRA-FINE II¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7274832
• MDR Text Key: 100209470
• Report Number: 1920898-2018-00103
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• Combination Product (y/n): N
• PMA/PMN Number: K955235
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320468
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/15/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability