MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2017-11-08 for Q2 T CONNECTOR EXTENSION SET W/ Q2 T-SITE-CHECKVALVE, MICROBORE TUB 95701 manufactured by Quest Medical, Inc..
[92536512]
The device was not returned. The inventory on the device lot is depleted and an investigation could not be carried out on a device from the same lot. A dhr review was conducted and there were no non-conformities or deviations associated with the manufacturing of this device. The review showed no anomalies. A complaint history review for the last 24 months was also conducted and no similar issues were found. The root cause of the reported issue is unknown.
Patient Sequence No: 1, Text Type: N, H10
[92536513]
The product distributor reported an issue encountered by their customer when using the fluid delivery extension set. The report stated that a piece of the device broke off during delivery of anesthesia to a patient during a cataract procedure. They reported that the furthest port, the one at the 180 degree angle, is the one that completely disconnected from the rest of the tubing and that the extension that sits at a 90 degree angle to the main tubing was intact. They reported the break was very clean with n apparent mishandling or severe damage to the unit. There were no patient complications reported as a result of the alleged issue. The device was discarded by the customer and not returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00072 |
| MDR Report Key | 7011813 |
| Report Source | DISTRIBUTOR |
| Date Received | 2017-11-08 |
| Date of Report | 2017-11-08 |
| Date of Event | 2017-08-15 |
| Date Mfgr Received | 2017-08-17 |
| Date Added to Maude | 2017-11-08 |
| 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 | 3 |
| Brand Name | Q2 T CONNECTOR EXTENSION SET W/ Q2 T-SITE-CHECKVALVE, MICROBORE TUB |
| Generic Name | FLUID DELIVERY EXTENSION SET |
| Product Code | FPK |
| Date Received | 2017-11-08 |
| Model Number | 95701 |
| Catalog Number | 95701 |
| Lot Number | 0531267M05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 1. Required No Informationntervention | 2017-11-08 |