MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-05-30 for VAMP JR. KIT VAMPUNKNOWN manufactured by Edwards Lifesciences Dr.
[76201120]
We received one single dpt - vamp jr for examination. The reported event was confirmed. The pressure tubing was detached from the proximal one-way shut-off valve (stopcock) solvent bond joint of the vamp system. The tubing was bent at the point of detachment. Indication of bonding solvent was visible on some locations but not throughout tubing bond area. The tubing outer diameter near the point of detachment was within specification. No other visible damage or defect was observed from returned kit. Lot number was not provided, therefore review of the manufacturing records could not be completed. An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint. Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review. Detached tubing will most likely occur during manipulation of the product by the clinician. Because the clinician is present, the stopcock can be used to stop the flow of blood, preventing blood loss. The system can be exchanged easily for another one, causing a minor delay in treatment or monitoring.
Patient Sequence No: 1, Text Type: N, H10
[76201121]
It was reported that during use, a break/crack was observed distal to the stopcock therefore there was no leakage. No patient complications reported. Another vamp jr was used and worked successfully. Inquired of patient demographics. Unable to be obtained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2017-01523 |
| MDR Report Key | 6598400 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-05-30 |
| Date of Report | 2017-04-28 |
| Date of Event | 2017-04-26 |
| Date Mfgr Received | 2017-04-08 |
| Date Added to Maude | 2017-05-30 |
| 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 | MR BRIAN HURD-SERVIN |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492506423 |
| Manufacturer G1 | EDWARDS LIFESCIENCES DR |
| Manufacturer Street | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 |
| Manufacturer City | HAINA, SAN CRISTOBAL |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VAMP JR. KIT |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2017-05-30 |
| Returned To Mfg | 2017-05-05 |
| Model Number | VAMPUNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES DR |
| Manufacturer Address | PARQUE INDUSTRIAL DE ITABO CARR. SANCHEZ KM 18.5 HAINA, SAN CRISTOBAL DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-30 |