MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-10 for EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT 27303 manufactured by Medtronic Neurosurgery.
[178636715]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[178636716]
It was reported that when the night shift was taking over the shift, they found that part of the fixed patch on the patient's waist pool had rolled edges and informed the doctor to replace the patch. After the doctor finished the treatment of the patient, it was found that the lumbar cistern catheter was broken in two pieces. The catheter was removed, and the patient's status at the time of the report was alive-with injury. The patient was being treated for cerebral hemorrhage.
Patient Sequence No: 1, Text Type: D, B5
[182252029]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182252030]
Additional information received reported that there were no environmental/external/patient factors that may have led or contributed to the issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2021898-2020-00060 |
| MDR Report Key | 9690086 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-10 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-05 |
| Date Mfgr Received | 2020-02-17 |
| Device Manufacturer Date | 2019-04-24 |
| Date Added to Maude | 2020-02-10 |
| 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 | KATCHA TAYLOR |
| Manufacturer Street | 9775 TOLEDO WAY |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9496801345 |
| Manufacturer G1 | MEDTRONIC NEUROSURGERY |
| Manufacturer Street | 125 CREMONA DRIVE |
| Manufacturer City | GOLETA CA 93117 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 93117 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXTERNAL DRAINAGE AND MONITORING, LUMBAR DRAINAGE KIT |
| Generic Name | DEVICE, MONITORING, INTRACRANIAL PRESSURE |
| Product Code | GWM |
| Date Received | 2020-02-10 |
| Model Number | 27303 |
| Catalog Number | 27303 |
| Lot Number | 217255947 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROSURGERY |
| Manufacturer Address | 125 CREMONA DRIVE GOLETA CA 93117 US 93117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2020-02-10 |