MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER INT. EVA TDC VITRECTOMY PACK VGPC INPUT 27G; SURGICAL PACKS AND KITS

Catalog Number 8310.27G12

Device Problem Unsealed Device Packaging (1444)

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

Event Date 12/15/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint is under investigation.

Event Description

We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

Manufacturer Narrative

In regard to this event, the product was recently returned for investigation.Please note that the investigation to determine the root cause of the reported event is ongoing.

Event Description

We were informed that the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

Manufacturer Narrative

Though the complaint form indicated that the tyvek lids on the blisters were not sealed properly, a subsequent email from customer service stated that "the packs were not unsealed, but broken".In regard to this complaint, two 27 gauge eva tdc vitrectomy packs were returned for investigation.Visual inspection of the returned product confirmed the presence of cracks in the blisters.Since all blister packs are visually inspected prior to being released for distribution, the observed damage must have occurred after the product left the controls of dorc.The observed cracks suggest transport damage; however, since no information was received on the state of the secondary packaging, improper handling of the blisters after they were removed from the cardboard box cannot be ruled out.The risk identified is included in the risk management documentation.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 the tyvek lid on the blister is not properly sealed.The product has not been used.No patient harm occured.

• Brand Name: EVA TDC VITRECTOMY PACK VGPC INPUT 27G
• 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: 13348390
• MDR Text Key: 287267994
• Report Number: 1222074-2022-00006
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 04/19/2022

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: 8310.27G12
• Device Lot Number: 2000427169
• 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; Not provided
• Supplement Dates FDA Received: 03/08/2022; 04/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1