MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-05-23 for Q2 T-EXTENSION SET, 7 INCH 95904 manufactured by Quest Medical, Inc..
[109116653]
Two (2) used samples and eight (8) unused samples were received from the customer for evaluation. Additional information received from the customer indicated the alleged defect for the first used sample as leaking and the alleged defect for the second sample as difficulty flushing the port. The 8 unused samples were dunk tested at 45 psi pressure for 1 min and no leakage was observed as the samples all functioned as intended. During evaluation of the used sample which was alleged to have issues with flushing the port, increased resistance was observed as a result of the presence of two check valves instead of one per the device specifications. The root cause of the increased resistance to flush the port is assembly error. No corrective action is being taken at this time for this defect, as this is an isolated occurrence. Quest will continue to monitor complaints for trends to re-evaluate the need for a corrective action. During evaluation of the sample which was alleged to have leaked, no leakage was identified during the decontamination process. Following decontamination, the sample was connected to a water inlet i with the open ends capped and water was run through the manifold for approximately 6 hours. No leakage wa seen at the port which was identified by the customer as leaking. Leakage was however subsequently seen coming from cracks on one of the double t-sites. Further investigation revealed that the cracks, where leaking was observed, resulted from the use of bleach in decontaminating the device at quest medical before the device evaluation. The point of leakage alleged by the customer could not be confirmed as manufacturing related.
Patient Sequence No: 1, Text Type: N, H10
[109116654]
A report was received regarding an alleged issue encountered with the q2 t-extension set. The report states that the customer's facility experienced leaking ports on 5 of the extension sets within a 24 hour period. According to the customer, one of the patients on whom the leaking device was used, had to be given fluid and inotropic resuscitation due to the epi leaking out while another patient had to be given extra boluses due to the sedation gtts leaking.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1649914-2018-00045 |
| MDR Report Key | 7538962 |
| Report Source | USER FACILITY |
| Date Received | 2018-05-23 |
| Date of Report | 2018-05-22 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2018-05-23 |
| 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-EXTENSION SET, 7 INCH |
| Generic Name | INTRAVASCULAR ADMINISTRATION SET |
| Product Code | FPK |
| Date Received | 2018-05-23 |
| Returned To Mfg | 2018-05-04 |
| Model Number | 95904 |
| Lot Number | 0526447J03; 0547567D01 |
| Operator | NURSE |
| Device Availability | R |
| 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 | 2018-05-23 |