MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-21 for Q2 EXTENSION SET, 17 INCH 95902 manufactured by Quest Medical, Inc..
[29214071]
Quest medical, inc. Has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported. Quest medical, inc. Defers to the patient's physician regarding medical history.
Patient Sequence No: 1, Text Type: N, H10
[29214072]
Additional information for the event reported on this date: the infusate was carmustine. The report stated that the alleged occlusion occurred after the drug had completed about half to three quarters of infusion. As a result, the bag was disconnected and the pharmacy re-calibrated the amount remaining to be infused and set up a new bag. The report stated all new tubing was sut up and the remainder of the drug was administered without complications. Reference manufacturer report numbers: 1649914-2015-00087, -00088, -00089, -00090, -00091.
Patient Sequence No: 1, Text Type: D, B5
[31404481]
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 | 1649914-2015-00092 |
| MDR Report Key | 5163531 |
| Date Received | 2015-10-21 |
| Date of Report | 2015-11-06 |
| Date of Event | 2015-09-24 |
| Date Mfgr Received | 2015-09-28 |
| Device Manufacturer Date | 2015-06-11 |
| Date Added to Maude | 2015-10-20 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | Q2 EXTENSION SET, 17 INCH |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2015-10-21 |
| Model Number | 95902 |
| Lot Number | 0492575E05 |
| Device Expiration Date | 2018-06-10 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| 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 | 2015-10-21 |