MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-02 for OPTISITE ARTERIAL CANNULAE OPTI20 manufactured by Edwards Lifesciences.
[138416120]
Evaluation summary: as received, a small tear approximately 2mm long was found on the sealed pouch packaging of returned device (see figure 2). No other visual damage, contamination, or other abnormalities were found to the sealed sterile barrier pouch packaging and device. Photos attached by complaint handler appeared consistent with lab findings. Any packaging non-conformance that results in a breach of the sterile package (i. E. Pinhole, tear or seal issue), has the potential to result in a serious infection. In this case, there was no report of patient injury. Per the product evaluation, the report of "a small hole was found in the package of the optisite cannula" was confirmed. Engineering task has been opened for further investigation. A supplemental report will be submitted upon completion.
Patient Sequence No: 1, Text Type: N, H10
[138416121]
It was reported by the warehouse in (b)(6) that a small hole was found in the package of the arterial cannulae during incoming inspection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008500478-2019-00110 |
| MDR Report Key | 8384344 |
| Date Received | 2019-03-02 |
| Date of Report | 2019-01-18 |
| Date of Event | 2019-01-17 |
| Date Mfgr Received | 2019-04-16 |
| Device Manufacturer Date | 2018-12-14 |
| Date Added to Maude | 2019-03-02 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. AMRITHA SRINIVASAN |
| Manufacturer Street | 1 EDWARDS WAY MLE2 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492504062 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | 1 EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | OPTISITE ARTERIAL CANNULAE |
| Generic Name | ARTERIAL CANNULAE |
| Product Code | DQR |
| Date Received | 2019-03-02 |
| Returned To Mfg | 2019-02-04 |
| Model Number | OPTI20 |
| Catalog Number | OPTI20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-02 |