MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2015-02-19 for NAVILYST MEDICAL H965907012421 manufactured by Navilyst Medical.
[18654399]
As reported by navilyst medical's distribution in (b)(6) a hospital has reported that when using a navilyst medical pressure monitoring line, air (and blood backflow) entered the line at the connection to a blood pressure monitoring transducer (not a navilyst medical device). The line was replaced, and the procedure continued. There was no air injection or patient injury. The used device has been returned to navilyst medical.
Patient Sequence No: 1, Text Type: D, B5
[19074888]
A review of the device history records was performed for the indicated packaging and component lots for any deviations related to the reported defect of the complaint. The review confirms that the lots met all material, assembly and performance specifications. The (b)(4) 2014 navilyst medical complaint report was reviewed for the product family of pressure monitoring lines and the failure mode "air bubbles. " no adverse trends were indicated. Initial inspection of the returned pressure monitoring line (pml) showed no damage or defects. Microscopic inspection of the luers did not reveal any cracks. The female and male tapers, as well as the female threads were measured and all were found to be within dimensional specification. The device was then air leak tested per navilyst medical procedures, and passed. The reported problem of air entry was unable to be confirmed, as the returned sample was found to be visually and functionally acceptable. It is possible that the end user did not adequately secure the connection between the pml and the transducer. The directions for use provided with the pml contains the caution, "ensure that you are making secure connections when using this device to prevent the introduction of air into the system. All connections should be finger-tightened. Over-tightening can cause cracks and leaks to occur. Examine product carefully for entrapped air and fully debubble prior to injection to minimize the potential for embolism. " (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1317056-2015-00056 |
| MDR Report Key | 4539643 |
| Report Source | 01,05,08 |
| Date Received | 2015-02-19 |
| Date of Report | 2015-01-22 |
| Date of Event | 2015-01-15 |
| Date Mfgr Received | 2015-01-22 |
| Device Manufacturer Date | 2012-12-01 |
| Date Added to Maude | 2015-03-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL DUERR |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424571 |
| Manufacturer G1 | NAVILYST MEDICAL |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12801 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NAVILYST MEDICAL |
| Generic Name | TUBING, PRESSURE MONITORING |
| Product Code | OBI |
| Date Received | 2015-02-19 |
| Returned To Mfg | 2015-01-29 |
| Model Number | NA |
| Catalog Number | H965907012421 |
| Lot Number | 4535225 |
| ID Number | PRESSURE MON. LINE |
| Device Expiration Date | 2015-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NAVILYST MEDICAL |
| Manufacturer Address | GLENS FALLS NY US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-19 |