MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-28 for SADDLELOOP 18GX10CM WITH BLUNT NEEDLE 1541 manufactured by Quest Medical, Inc..
[63742231]
The international distributor ((b)(4)) reported an issue encountered with the saddleloop device during use. The clinician reported that the tubing was not locked into the slot of the keyhole as expected. The locking mechanism was detached from the tubing and was loose in the package. The report stated another package of the same device was used instead to complete the procedure. There were no patient complications reported as a result of the alleged issue. The device was returned to the manufacturer for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[68478574]
Examination of the returned device confirmed the alleged complaint. The tensioner was off of the tape. Visual examination under black light found that no adhesive was present on the device. Adhesive is required to hold the tensioner on the device. The adhesive dispenser was not functioning properly, resulting in inadequate amounts of adhesive applied. The device history record for the lot was reviewed and no devices were rejected and no specific manufacturing yield issues were reported similar to the reported complaint condition.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2016-00065 |
| MDR Report Key | 6210153 |
| Date Received | 2016-12-28 |
| Date of Report | 2017-02-20 |
| Date of Event | 2016-11-21 |
| Date Mfgr Received | 2016-12-05 |
| Device Manufacturer Date | 2015-10-02 |
| Date Added to Maude | 2016-12-28 |
| 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 | MRS. AMY CLENDENING-WHEELER |
| 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 | SADDLELOOP 18GX10CM WITH BLUNT NEEDLE |
| Generic Name | VASCULAR LOOP |
| Product Code | GAE |
| Date Received | 2016-12-28 |
| Returned To Mfg | 2016-12-07 |
| Model Number | 1541 |
| Lot Number | 0499345C01 |
| Device Expiration Date | 2019-10-01 |
| 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 | 1. Required No Informationntervention | 2016-12-28 |