MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-17 for Q2 IV EXTENSION SET 95906 manufactured by Quest Medical, Inc.
[114619653]
The facility was contacted several times to request for information about the reported incident and responses received indicate the facility has no knowledge of the incident. No information has been provided by the facility to aid in the investigation. No complaint sample was returned for evaluation. The dhr review did not identify any anomalies related to the reported complaint condition. A follow up medwatch will be submitted if additional information is received.
Patient Sequence No: 1, Text Type: N, H10
[114619654]
A copy of a medwatch was received by quest medical on 6/28/2018. The medwatch states that a nurse was flushing the line and there was a "sudden resistance" at which time the cap came off and fluid sprayed out of the pivo connection port into her eye, face and arm.
Patient Sequence No: 1, Text Type: D, B5
[132398015]
Additional information received during an on site visit to the user facility indicates that the incident occurred. The user facility stated that during the procedure, the nurse felt resistance but continued to flush the line at which time, the fluid sprayed through the q2 device. A suspected cause of the complaint condition is an occluded iv catheter where the potency of the catheter may not have being verified before injection in line with hospital protocols. Review of the manufacturing process did not show any process anomaly at the time of investigation. During manufacturing, the parts are aql sampled and inspected for leak. All the inspection equipment were found to be calibrated. The root cause of the incident is not manufacturing related.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1649914-2018-00068 |
| MDR Report Key | 7696739 |
| Date Received | 2018-07-17 |
| Date of Report | 2018-10-03 |
| Date Mfgr Received | 2018-06-28 |
| Date Added to Maude | 2018-07-17 |
| 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 | Q2 IV EXTENSION SET |
| Generic Name | IV EXTENSION SETS |
| Product Code | FPK |
| Date Received | 2018-07-17 |
| Model Number | 95906 |
| Lot Number | 054872 |
| 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 | 2018-07-17 |