MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.3ML 31GX5/16"; INSULIN SYRINGE AND NEEDLE

Catalog Number 328438

Device Problem Insufficient Information (3190)

Patient Problems Blurred Vision (2137); Device Embedded In Tissue or Plaque (3165)

Event Date 05/22/2017

Event Type  Injury  

Manufacturer Narrative

A sample is not available for evaluation.A review of the device history record revealed one notification (b)(4) for a defect noted during production that is unrelated to this complaint topic.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.(b)(4).

Event Description

It was reported that an eye surgeon indicated that during eye injections with bd insulin syringes with the bd ultra-fine¿ needle 0.3ml 31gx5/16", residual silicone is left in his patients eyes.This causes a blurry floating spot in the patients vision which cannot be removed.There was no report of medical intervention.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE¿ NEEDLE 0.3ML 31GX5/16"
• Type of Device: INSULIN SYRINGE AND NEEDLE
• 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: 6645888
• MDR Text Key: 77700343
• Report Number: 1920898-2017-00073
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 328438
• Device Lot Number: 6291665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/15/2017
• 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): Disability