MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-01-16 for RAPID? SPINAL NEEDLE SET 100/496/126 manufactured by Smiths Medical Asd, Inc..
[64920699]
Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10
[64920700]
It was reported the tip of the rapid? Spinal 26g pencil point needle broke off while inserting the needle into the patient and an additional attempt for spinal anesthesia was abandoned. The patient then underwent general anesthesia for a routine caesarian section. The patient's pregnancy was at full term. It was further reported after the caesarian section a neurosurgeon performed an emergency procedure which included a 'mini incision' in the patient's back to remove the spinal needle.
Patient Sequence No: 1, Text Type: D, B5
[74719575]
One needle 26g*90mm spinal pencil (part number: 005/000/056, lot number: kb5l834) was returned for investigation. The sample was received with the certificate of safe handling and was not in the original packaging. There was no brown button on the hub of the needle and there was no protective sheath returned with the defected sample. The broken piece, which was removed from the patient, was not returned. Visual inspection of the returned sample revealed that the needle was bent approximately 25mm from the needle hub and that the needle was broken approximately 49mm from the needle hub. No further examination was able to be performed as the only part of the needle was returned. Investigation was unable to definitively determine the root cause of the broken and bent needle. The supplier of the needle component was made aware of the reported issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-00168 |
| MDR Report Key | 6254805 |
| Report Source | OTHER |
| Date Received | 2017-01-16 |
| Date of Report | 2017-05-02 |
| Date of Event | 2016-12-13 |
| Date Mfgr Received | 2017-04-12 |
| Device Manufacturer Date | 2016-03-11 |
| Date Added to Maude | 2017-01-16 |
| 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. LISA PERZ |
| Manufacturer Street | SMITHS MEDICAL ASD, INC. 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS, MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833074 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD. |
| Manufacturer Street | 52 GRAYSHILL ROAD |
| Manufacturer City | CUMBERNAULD, GLASGOW G68 9HQ |
| Manufacturer Country | UK |
| Manufacturer Postal Code | G68 9HQ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPID? SPINAL NEEDLE SET |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2017-01-16 |
| Returned To Mfg | 2017-01-30 |
| Catalog Number | 100/496/126 |
| Lot Number | 3145832 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Other; 2. Required No Informationntervention | 2017-01-16 |