MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-07-20 for PORTEX? SPINAL NEEDLE SET 100/496/126 manufactured by Smiths Medical Asd, Inc..
[80618526]
Customer has not returned the device to the manufacturer for device evaluation. 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
[80618527]
It was reported that a the needle of a portex? Spinal needle set broke, and about 3cm of the needle remained between the patient's vertebrae. The patient has having a caesarean section at the time of the event. The patient had a radiology scan and was then transferred to the neurological hospital "in emergency" to remove the needle. The surgery lasted three hours. The needle was removed successfully. The patient received amoxicillin/clavulanic acid and "the usual treatment post caesarean". No permanent injury was reported.
Patient Sequence No: 1, Text Type: D, B5
[104573619]
One spinal pencil and one introducer was returned for evaluation. Visual inspection found that the spinal pencil needle was broken at 3. 5cm from the tip of the needle. A review of the testing and inspection process was performed and showed that a minimum of 5 samples were tested for penetration and strength of the supplied needles as well as bends and kinks in the supplied stylets. The supplier of the needle was unable to be identified and therefore, the device analysis was limited and a root cause was unable to be determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3012307300-2017-01547 |
| MDR Report Key | 6729385 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-07-20 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-07-04 |
| Date Mfgr Received | 2017-09-13 |
| Date Added to Maude | 2017-07-20 |
| 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 | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JENNIFER MENG |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833078 |
| 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 | PORTEX? SPINAL NEEDLE SET |
| Generic Name | NEEDLE, SPINAL, SHORT TERM |
| Product Code | MIA |
| Date Received | 2017-07-20 |
| Returned To Mfg | 2017-08-01 |
| Catalog Number | 100/496/126 |
| Operator | HEALTH PROFESSIONAL |
| 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. Required No Informationntervention | 2017-07-20 |