MAUDE Adverse Event Report: BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE WITH 5 MICRON THIN WALL

Catalog Number 305200

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Endophthalmitis (1835); Hypopyon (1913); Unspecified Infection (1930); Loss of Vision (2139)

Event Date 03/07/2016

Event Type  Injury  

Manufacturer Narrative

The date received by manufacturer has been used for this field.Medical device expiration date: unknown.(b)(4).Device manufacture date: unknown.Results: a sample is not available for evaluation.A review of the device history record could not be performed as a lot number for this incident was not provided.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.Additionally, bd has reviewed the complaint history for this cat # and was unable to find any complaints associated with corynebacterium.We do not feel that our device is associated with this bacteria.

Event Description

It was reported that a 19 g x 1 1/2 in.Bd nokor¿ filter needle with 5 micron thin wall was used as part of an intravitreal injection of anti-vascular endothelial growth factor (anti-vegf) agents.Three days after lucentis injection, the patient presented with reduced visual acuity (counting finger), conjunctival injection (conjunctival hyperaemia), anterior chamber cell with hypopyon (hypopyon), and vitreous cell (vitreous disorder).Culture results of anterior chamber aspirate showed corynebacterium (corynebacterium infection).On an unknown date, the patient was diagnosed with endophthalmitis.The patient received a vitreous tap (tap/inject) with intravitreal injection of vancomycin and ceftazidime.The outcome of the event was not reported.After 23 months follow up, the patient's final visual acuity was 20/80.Linked to mdr #1911916-2016-00004.

• Brand Name: 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE WITH 5 MICRON THIN WALL
• Type of Device: FILTER NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS; 920 e 19th street; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS; 920 e 19th street; columbus NE 68601
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5542816
• MDR Text Key: 41718899
• Report Number: 1911916-2016-00005
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 305200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention