MAUDE Adverse Event Report: MEDICAL WORKSHOP B.V. INVITRIA OPHTHALMIC SPECULUM; SPECULA, OPHTHALMIC

Catalog Number MW-200-P

Device Problem Gas/Air Leak (2946)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

Six pts from a single hosp in the (b)(6) were cultured for presumed ocular infections between (b)(6) 2018 and (b)(6) 2019.Each had intravitreal injections performed for which positioning was aided by use of the invitria device.The invitria functions as a speculum to hold the eyelids open and aids in the correct positioning of the needle/syringe used to perform an intravitreal injection.The invitria is non-invasive and is in contact with the surface of the cornea for a few mins while the injection is being performed.The invitria is manufactured by medical workshop, and is distributed exclusively by (b)(4) with import and distribution into the u.S.By (b)(4).(b)(4) distributor ((b)(4)) reported a possible device related adverse event to (b)(4) on (b)(6) 2019, that (b)(4) received from (b)(6) hosp ((b)(6)).Between (b)(6) 2018 and (b)(6) 2019, 6 cases of suspected ocular infections occurred after intravitreal injections.Cultures were positive for coagulase negative staphylococcus in 2 cases; staphylococcus epidermidis in 1 case; cultures were negative in 2 cases; and, cultures were not obtained in 1 case.The invitria device had been used for each case.Hosp personnel reported the invitria package appeared to leak air when compressed and were concerned the packaging sterility may have been compromised.The suspect invitria devices were from 2 different mfg lots (09244-18; 12988-18).The invitria devices are packaged in (b)(4), which have microscopic pores that enable ethylene oxide gas to dissipate but are too small to allow microbial organisms to pass across the packaging, and is a well-known material.U.S.Distributor: (b)(4).

• Brand Name: INVITRIA OPHTHALMIC SPECULUM
• Type of Device: SPECULA, OPHTHALMIC
• Manufacturer (Section D): MEDICAL WORKSHOP B.V. ; groningen ; NL
• MDR Report Key: 8758038
• MDR Text Key: 150299060
• Report Number: MW5087789
• Device Sequence Number: 1
• Product Code: HNC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2019
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MW-200-P
• Device Lot Number: 09244-18
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1