MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-03-01 for Q2 CHECKMATE EXTENSION SET 44 INCH. 9541 manufactured by Quest Medical, Inc..
[68748916]
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
[68748917]
The nurse reported an issue occurred with the iv administration extension set during use. She stated the set leaked during use. Follow-up with the complainant found that the tubing was loose and the connector kept rotating; it was not tightening. The report stated the patient was hiv positive and the leak resulted in a large amount of blood on the floor. The lot number was not provided. The device was discarded by the hospital and will not return for evaluation. Additional follow-up attempts have not been successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2017-00014 |
| MDR Report Key | 6368206 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-03-01 |
| Date of Report | 2017-02-01 |
| Date of Event | 2017-02-01 |
| Date Mfgr Received | 2017-02-01 |
| Date Added to Maude | 2017-03-01 |
| 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 | Q2 CHECKMATE EXTENSION SET 44 INCH. |
| Generic Name | INTRAVASCULAR ADMINISTRATION EXTENSION SET |
| Product Code | FPK |
| Date Received | 2017-03-01 |
| Model Number | 9541 |
| Operator | PHYSICIAN |
| 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 | 2017-03-01 |