MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2004-10-08 for NEOTREND-L SENSOR N7004L manufactured by Diametrics Medical, Ltd..
[710181]
Neotrend-l sensor calibrated without issue and an attempt to insert into a dmi 3. 7 fr uac. During the initial sensor advancement maneuver, the sensor would not extend out of the y-port. By the second attempt, blood began backing up the uac and then into the sensor. The sensor was removed from the uac and discarded. No report of harm or injury to the pt has been rec'd.
Patient Sequence No: 1, Text Type: D, B5
[8124637]
It was reported that difficulties were experienced during the attempted insertion of a neotrend-l sensor into a 3. 7 fr dmi umbilical artery catheter (uac). During the initial sensor advancement maneuver, the sensor would not extend out of the y-piece. By the second attempt, blood began backing up the uac and into the sensor. The neotrend-l sensor was removed from the uac and discarded by the customer. This prevented a full investigation from being performed. Investigations into similar incidents reported recently have determined that resistance encountered during sensor insertion may be caused by the neotrend-l y-piece seal not permitting the smooth passage of the sensor. Investigations indicate that the butt weld, the join between the narrow diameter of the sensing region of the sensor and the solid wall, may be subject to frictional forces, which makes the sensor more difficult to insert. Repeated and inappropriate attempts by the user to insert and withdraw the sensor may result in the buckling of the sensor towards the proximal end, effectively shortening the sensor length. Once shortened, the butt weld can pass into or through the y-piece seal providing a fluid path beyond the y-piece. Dml is in the process of making design modifications to the sensor y-piece and to protect against inappropriate use, which may lead to blood leakage. Without the return of the neotrend-l sensor, dml is unable to determine conclusively the cause of the reported blood leakage into the sensor detailed in this incident.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9612233-2004-00023 |
| MDR Report Key | 904467 |
| Report Source | 06 |
| Date Received | 2004-10-08 |
| Date of Report | 2004-09-16 |
| Date of Event | 2004-09-16 |
| Date Mfgr Received | 2004-09-16 |
| Device Manufacturer Date | 2004-03-01 |
| Date Added to Maude | 2007-08-30 |
| 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 |
| Reporter Occupation | RESPIRATORY THERAPIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MISS J WALTERS |
| Manufacturer Street | SHORT STREET |
| Manufacturer City | HIGH WYCOMBE, BUCKS HP112QH |
| Manufacturer Country | UK |
| Manufacturer Postal | HP11 2QH |
| Manufacturer Phone | 494471671 |
| Manufacturer G1 | DIAMETRICS MEDICAL LIMITED |
| Manufacturer Street | GEORGE STREET |
| Manufacturer City | HIGH WYCOMBE, BUCKS HP112XJ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HP11 2XJ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEOTREND-L SENSOR |
| Generic Name | BLOOD GAS MONITORING SYSTEM |
| Product Code | CCE |
| Date Received | 2004-10-08 |
| Model Number | N7004L |
| Catalog Number | N7004L |
| Lot Number | 919 |
| ID Number | * |
| Device Expiration Date | 2005-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 879245 |
| Manufacturer | DIAMETRICS MEDICAL, LTD. |
| Manufacturer Address | GEORGE ST. HIGH WYCOMBE, BUCKS. UK HP11 2XJ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-10-08 |