MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. DISPOSABLE ONE STEP CANNULA SYSTEM (25 GAUGE / 0.5 MM); OPHTHALMIC CANNULATION SET, SINGLE-USE

Catalog Number 1272.ED205

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Complaint article was received by d.O.R.C.Investigation is ongoing.

Event Description

The customer reported that no label was present on a packaging of the cannula system.The product was not used.No patient harm occurred.

Event Description

The customer reported that no label was present on a packaging of the cannula system.The product was not used.No patient harm occurred.

Manufacturer Narrative

With regards to this complaint, the one disposable one step cannula system was received for investigation.Visual inspection of the returned product confirmed the absence of a label at the pouch.The missing label is considered a manufacturer related failure; however, since the lot number of the returned product was not provided, device history record review pertinent to the lot could not be performed and a possible cause could not be determined.Based upon the available information the reported complaint is considered to be manufacturer related.Review of the complaint database did not identify similar issues.Complaints will be closely monitored to identify any significant adverse trends.

• Brand Name: DISPOSABLE ONE STEP CANNULA SYSTEM (25 GAUGE / 0.5 MM)
• Type of Device: OPHTHALMIC CANNULATION SET, SINGLE-USE
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, ; NL
• MDR Report Key: 10380180
• MDR Text Key: 205099396
• Report Number: 1222074-2020-00056
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 1272.ED205
• Device Lot Number: NOT AVAILABLE
• Patient Sequence Number: 1