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

Catalog Number 1272.EDPP5

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

We were informed that prior to use, foreign material was noticed on the instrument.Therefore, the product was not used.No patient harm occurred.

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that prior to use, foreign material was noticed on the instrument.Therefor the product was not used.No patient harm occurred.

Manufacturer Narrative

In regards to this complaint, four inserter-cannula combinations from a 25 gauge disposable one step single cannula system were received for investigation.In addition, one inserter was received without a cannula.Visual inspection confirmed the presence of a white substance on the cannula's.Based on its appearance and the fact that it could easily be wiped off, it was determined that the substance was in fact precipitated vapor from the glue that was used during product assembly (i.E.No foreign material with unknown impact on biocompatibility).Based on the investigation performed, it was determined that the reported event is attributable to an human error during quality control.Please note that actions have been taken to prevent re-occurrence of the reported event in the future.The risks and mitigations associated with the reported issue are identified in existing risk documents and no new risks were identified as part of this investigation.Trend analysis indicates that the product is performing within anticipated rates.Complaints will be closely monitored to identify any significant adverse trends.

• Brand Name: DISPOSABLE ONE STEP SINGLE CANNULA INCLUDING INSERTER. (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, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: danielle sleegers ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 13341072
• MDR Text Key: 287269572
• Report Number: 1222074-2022-00005
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1272.EDPP5
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1