MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-24 for CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH 821731 manufactured by Natus Neuro Incorporated.
[134360747]
(b)(4). Based on investigation information, eds iii visually inspected, confirmed patient line stop cock was cracked. Root cause determined to be over tightening due to atypical force when attaching tubes to the patient line stop cock, as noted in the ifu finger tighten when attaching devices.
Patient Sequence No: 1, Text Type: N, H10
[134360748]
Eds3 leaked fluid from the three way tap following patient being rolled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010611950-2019-00001 |
| MDR Report Key | 8274764 |
| Date Received | 2019-01-24 |
| Date of Report | 2019-01-15 |
| Date of Event | 2018-09-19 |
| Date Mfgr Received | 2019-01-15 |
| Date Added to Maude | 2019-01-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JANESSA BOONE |
| Manufacturer Street | 3150 PLEASANT VIEW ROAD |
| Manufacturer City | MIDDLETON WI 53562 |
| Manufacturer Country | US |
| Manufacturer Postal | 53562 |
| Manufacturer Phone | 6088298603 |
| Manufacturer G1 | NATUS NEUROLOGY INCORPORATED |
| Manufacturer Street | 5955 PACIFIC CENTER BOULEVARD |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH |
| Generic Name | SHUNT, CENTRAL NERVOUS SYSTEM & COMPS |
| Product Code | PSP |
| Date Received | 2019-01-24 |
| Returned To Mfg | 2018-11-16 |
| Model Number | 821731 |
| Catalog Number | 821731 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS NEURO INCORPORATED |
| Manufacturer Address | 3150 PLEASANT VIEW ROAD MIDDLETON WI 53562 US 53562 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-24 |