MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-13 for STENTUBE LACRIMAL INTUBATION SET manufactured by Quest Medical, Inc.
[100270207]
The device is being evaluated. A follow medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[100270208]
A report was received regarding an alleged issue encountered during use of the lacrimal intubation set. The report states that he surgeon was unable to use the stent due to defective traits. Specific details were not give. Upon receipt of the complaint samples, the probe was found to have detached from the tubing. There were no reported patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
[132407649]
Two complaint samples were received and evaluated. Evaluation of the first sample showed detachment of the probe from one end of the silicone tube and a tear on the other end of the tube. Evaluation of the second sample showed detachment of one probe, while the other probe was still attached. Pull force testing was performed on the attached probe and the maximum pull force recorded was 1. 15lb which is greater than the pull force specification of >1. 0lbs, per internal inspection procedure which requires pull force check during the manufacturing process. A dhr review was conducted on the lot complained about and no anomalies were identified. The root cause of issue is not manufacturing related and is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2018-00020 |
| MDR Report Key | 7268599 |
| Date Received | 2018-02-13 |
| Date of Report | 2018-03-29 |
| Date Mfgr Received | 2018-01-23 |
| Date Added to Maude | 2018-02-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TOSAN ONOSODE |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal | 75002 |
| Manufacturer Phone | 9723326338 |
| Manufacturer G1 | QUEST MEDICAL, INC. |
| Manufacturer Street | ONE ALLENTOWN PARKWAY |
| Manufacturer City | ALLEN TX 75002 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75002 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STENTUBE LACRIMAL INTUBATION SET |
| Generic Name | LACRIMAL INTUBATION SET |
| Product Code | OKS |
| Date Received | 2018-02-13 |
| Returned To Mfg | 2018-01-25 |
| Lot Number | 0528537J08 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | QUEST MEDICAL, INC |
| Manufacturer Address | ONE ALLENTOWN PARKWAY ALLEN TX 75002 US 75002 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-13 |