MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-22 for SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE 1541 manufactured by Quest Medical, Inc.
[112573630]
The alleged issue occurred outside of the us. A similar device is distributed by quest medical in the us. The device is expected to be returned and an investigation will be completed when the device is received. A follow up medwatch will be submitted if additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[112573631]
A report was received regarding an alleged issue with the device. The report states that when the hospital staff opened the device package, they observed that the tensioner on the saddleloop was almost detached from the saddleloop. There were no patient complications resulting from the alleged issue.
Patient Sequence No: 1, Text Type: D, B5
[132403611]
Investigation conducted showed inconsistencies in dispensing the adhesive which holds the components of the device together. The dhr review showed the device was however within specification having been subjected to a maximum tensioner break force of >1. 0 ibs without failing. Quest medical has implemented a process change as a proactive measure to prevent this issue. The process improvement involves a change in the needle size of the adhesive dispensing gauge for consistent adhesive dispensing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2018-00062 |
| MDR Report Key | 7629642 |
| Date Received | 2018-06-22 |
| Date of Report | 2018-01-17 |
| Date Mfgr Received | 2018-06-15 |
| Date Added to Maude | 2018-06-22 |
| 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 | SADDLELOOP 18G X 10CM WITH BLUNT NEEDLE |
| Generic Name | VASCULAR LOOP |
| Product Code | GAE |
| Date Received | 2018-06-22 |
| Model Number | 1541 |
| Lot Number | 049402 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-06-22 |