MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA CARTRIDGE WITH 0.5 L COLLECTION BAG; SURGICAL PACKS AND KITS

Catalog Number 8100.CAR11

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 05/02/2022

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that foreign material was noticed in the packaging.The product has not been used.No patient harm occurred.

Event Description

We were informed that foreign material was noticed in the packaging.The product has not been used.No patient harm occurred.

Manufacturer Narrative

The complaint article was received for investigation.Visual inspection confirmed the foreign material as described in the reported event.As the origin of the material could not be clearly determined within d.O.R.C., the product will be analyzed in a external laboratory.As soon as results are available, the root cause investigation will be continued.

Manufacturer Narrative

In regard to this complaint, one eva cartridge with 0.5 l collection bag was received for investigation.As received, the blister pack was unopened.Visual inspection confirmed the presence of a foreign material inside the blister.Since its origin could not be determined within dorc, the material was sent to sgs laboratories in belgium for forensic analysis.The results of the forensic investigation revealed that the material found in unopened pouch consisted of a combination of cellulose fibers and to a lesser extent calcium carbonate filler.Which indicates that the foreign material possibly originated from a piece of paper of carton.Device history record review revealed no deviations and a database search showed that no similar complaints have been reported on this specific lot previously.Please note that our operations are executed in a class 7 clean room environment to ensure minimum contamination and that these products are subject to 100% visual inspection prior to being released for distribution.Despite the control measures, the fiber was not detected before the product was released for distribution.Trend analysis indicates that the product is performing within anticipated rates.Therefore, no remedial or corrective/preventive actions will be undertaken at this moment.Complaints will be closely monitored to identify any significant adverse trends.

Event Description

We were informed that foreign material was noticed in the packaging.The product has not been used.No patient harm occurred.

• Brand Name: EVA CARTRIDGE WITH 0.5 L COLLECTION BAG
• Type of Device: SURGICAL PACKS AND KITS
• 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: 14352745
• MDR Text Key: 291363015
• Report Number: 1222074-2022-00039
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2022

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: 8100.CAR11
• Device Lot Number: 2000430986
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2022
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/16/2022; 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1