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 2018-07-03 for VAMP DIRECT-DRAW VMP700 manufactured by Edwards Lifesciences Dr.
[113041864]
It was reported that during use with vamp direct draw cannula the rn suffered a needle stick injury. The facility states? It was because of how the vacutainer has to be held/secured that led to the injury?. No further information was able to obtain at this time. Despite repeated attempts, no further information has been obtained regarding how the product was being used or the current status of the nurse. The device was not returned for evaluation; it was discarded at the hospital. Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event. No corrective actions will be taken at this time. If additional information is received, a supplemental report will be filed. A review of the manufacturing records indicated that the product met specifications upon release. Health care workers are at increased risk of needlestick injury, which occurs when the skin is accidentally punctured by a used needle. It is possible for blood-borne pathogens to be transmitted by such an injury. Before beginning a procedure using needles, the clinician should plan for safe handling and proper disposal of the needle. It is unknown whether user or procedural factors played a role in this event. 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. Udi #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[113041865]
It was reported that during use with vamp direct draw cannula the rn suffered a needle stick injury. The facility states? It was because of how the vacutainer has to be held/secured that led to the injury?. No further information was able to be obtain at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2015691-2018-02599 |
| MDR Report Key | 7659061 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-07-03 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-06-13 |
| Date Mfgr Received | 2018-06-13 |
| Device Manufacturer Date | 2018-02-21 |
| Date Added to Maude | 2018-07-03 |
| 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 | MS LYNN SELAWSKI |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9497564386 |
| 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 DIRECT-DRAW |
| Generic Name | KIT, SAMPLING, ARTERIAL BLOOD |
| Product Code | CBT |
| Date Received | 2018-07-03 |
| Model Number | VMP700 |
| Lot Number | 61252743 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 1. Other | 2018-07-03 |