MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE UNSPECIFIED BD INSULIN SYRINGE WITH 31 GAUGE NEEDLE

Catalog Number UNKNOWN

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

Patient Problems Visual Impairment (2138); No Code Available (3191)

Event Date 06/13/2016

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device lot #.The lot # reported by both the customer and the patient who sent the voluntary medwatch was (b)(4) however, this lot # is not valid.Multiple attempts have been made to obtain additional information, but as of the date of this report, no additional information has been received.Medical device expiration date: unknown device manufacture date: unknown results: a sample was not returned for evaluation.A review of the device history record could not be performed as the lot number provide for this incident is invalid.In the event that new, changed, or corrected information is obtained, a supplemental report will be filed.Conclusion: 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.Additionally, our quality engineer notes that a google search on the drug avastin (the drug that was administered to the patient), revealed that the customer's experience is similar to the common side effects of this drug.

Event Description

The initial notification date for this complaint was 6/13/2016.It was previously reviewed and found to be a non-reportable incident as no injury or medical interventions were reported.On (b)(6) 2016, bd received medwatch # mw5063712 which reported that the patient suffered visual impairment.Therefore, this incident was re-evaluated and determined to be mdr reportable on 8/24/2016.It was reported that a patient received an injection of the drug avastin in his left eye for macular degeneration.The medication was drawn up in an unspecified bd insulin syringe with a 31 gauge needle.It was also reported that the medication is then refrigerated and stored up to three months prior to use but is usually used sooner.After receiving the avastin injection, the patient reported to have visual impairment, specifically stating, "i have 100 plus black dots floating around inside my eye and several very large black circles floating in my vision." the patient further stated that he felt that this was due to a lubricant or oil from the syringe that was injected into his eye.The patient states that he has seen two different eye surgeons and they both see material floating in his eye.As of the date of this report, there have been no reports of the patient receiving any medical or surgical interventions.

Manufacturer Narrative

Additional information: it was initially reported that the lot # for this incident was invalid and that multiple attempts had been made to verify the correct lot #.After no response was received from the initial reporter, the lot # was updated from 4531615 to unknown.Medical device lot #: unknown.

• Brand Name: UNSPECIFIED BD INSULIN SYRINGE WITH 31 GAUGE 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: 5922987
• MDR Text Key: 53782406
• Report Number: 1920898-2016-00028
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability