MAUDE Adverse Event Report: D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V. VFI PACK FOR SILICONE OIL SYRINGES; DISPOSABLE TAMPONADE ACCESSORIES

Catalog Number 1363.DD

Device Problem Break (1069)

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

Event Date 03/04/2023

Event Type  malfunction  

Event Description

We have been informed that during procedure, while putting silicone oil (sil-5000-s) in the eye, there was suddenly a loud bang and it turned out that the tip of the silicone oil syringe was broken.No abnormalities were found in the patients eye.The employees present were not harmed either.No report that surgical procedure was prolonged > 30 minutes.

Manufacturer Narrative

The complaint is under investigation.In case of a product return, the device will be investigated, otherwise we will review the device history record, and/or any log files if available, or try to replicate the problem on similar product.As investigations on the actual product or representative sample of a batch may alter the device, we request to inform us within 7 days after submission of this report, in case the investigations that alter the device should be halted until approval of the nca, as per article 89 of eu-mdr.

Event Description

We have been informed that during procedure, while putting silicone oil (sil-5000-s) in the eye, there was suddenly a loud bang and it turned out that the tip of the silicone oil syringe was broken.No abnormalities were found in the patients eye.The employees present were not harmed either.No report that surgical procedure was prolonged > 30 minutes.

Manufacturer Narrative

Initial visual inspection confirmed that the glass syringe was broken.Device history record review pertinent to the silicone oil syringe by our external manufacturing party is currently pending.

Manufacturer Narrative

In regard to this complaint, a vfi tube set (1363.Dd) was received for investigation together with a silicone oil syringe (sil-1000-s).Visual inspection of the returned product revealed that one of the barrel flanges of the syringe was broken.The vfi tube set showed no anomalies.To confirm any issue with the tube set, tests were performed with different new oil syringes.The syringes could be placed on the tube set adapter properly without suffering any damage.Based on the investigation, the damage to the oil syringe could not be directly attributed to the vfi tube set.Batch record review pertinent to the silicone oil syringe revealed that lot 33222 was released without deviations.All in-process controls and release tests were performed without deviation.Specifically, the incoming inspection of the used syringes and the process step final packaging, which includes 100% visual inspection, were reviewed.No issues were found with the incoming syringes and the packaging materials were released without deviation.Also the final packaging process step revealed no deviations.Though the damage to the syringe was most likely the result of an unintended use error (e.G., incorrect placement in the syringe adapter, impact damage, etc.), the rare presence of a weak spot in the glass syringe could not 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.Since the cause of the reported event was not established, remedial / corrective / preventive / field safety corrective (fsc) actions are deemed not necessary the analysis includes all complaints with failure mode sil-syringe-broken-surgery to date and the distribution figures of silicone oil syringes per may 26, 2023.

Event Description

We have been informed that during procedure, while putting silicone oil (sil-5000-s) in the eye, there was suddenly a loud bang and it turned out that the tip of the silicone oil syringe was broken.No abnormalities were found in the patients eye.The employees present were not harmed either.No report that surgical procedure was prolonged > 30 minutes.

• Brand Name: VFI PACK FOR SILICONE OIL SYRINGES
• Type of Device: DISPOSABLE TAMPONADE ACCESSORIES
• Manufacturer (Section D): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer (Section G): D.O.R.C. DUTCH OPHTHALMIC RESEARCH CENTER B.V.; scheijdelveweg 2; zuidland, 3214 VN; NL 3214 VN
• Manufacturer Contact: petra holland ; scheijdelveweg 2; zuidland, 3214 -VN ; NL 3214 VN
• MDR Report Key: 16582474
• MDR Text Key: 311874379
• Report Number: 1222074-2023-00027
• Device Sequence Number: 1
• Product Code: HQC
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1363.DD
• Device Lot Number: 2000435704 (2507153)
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1