MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-01-04 for PORTEX CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS 100/491/718 manufactured by Smiths Medical Asd, Inc..
[132112594]
Report source: (b)(6).
Patient Sequence No: 1, Text Type: N, H10
[132112595]
Information was received that a smiths medical portex csecure spinal and epidural needle assemblies - minipack was used on a patient noted to have a diagnosis of "nulliparous, (b)(6), rupture of membranes". The reporter stated the patient received an epidural infusion of bupivacaine with fentanyl prior to the combined spinal attempt and lidocaine subcutaneously just prior to insertion. The "cse was performed with loss of resistance to air technique. When no csf was identified (needed to confirm the intrathecal placement), the spinal needle was removed. Upon removal, the needle appeared kinked at the end and shorter. The epidural catheter was inserted through the touhy needle in order to provide the necessary analgesia. Under the impression that the spinal needle tip was broken, a ct of the lumbar spine demonstrated a fragment of metal near l2-3 left root". Subsequently, a neurosurgery consult was ordered and it was noted the patient had "conservative treatment". No additional adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2019-00080 |
| MDR Report Key | 8218192 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-04 |
| Date of Event | 2018-12-03 |
| Date Mfgr Received | 2018-12-06 |
| Device Manufacturer Date | 2018-05-31 |
| Date Added to Maude | 2019-01-04 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer G1 | SMITHS MEDICAL NORTH AMERICA |
| Manufacturer Street | 10 BOWMAN DRIVE |
| Manufacturer City | KEENE NH 034310724 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 034310724 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PORTEX CSECURE SPINAL AND EPIDURAL NEEDLE ASSEMBLIES - MINIPACKS |
| Generic Name | SPINAL EPIDURAL ANESTHESIA KIT |
| Product Code | OFT |
| Date Received | 2019-01-04 |
| Catalog Number | 100/491/718 |
| Lot Number | 3626764 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-01-04 |