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 2016-08-10 for PORTEX SPINAL ANESTHESIA KIT G973 manufactured by Smiths Medical Asd Inc..
[51812748]
The device is currently being evaluated; the manufacturer will file a follow-up report detailing the results of the evaluation once it is completed.
Patient Sequence No: 1, Text Type: N, H10
[51812749]
This event occurred in (b)(6). It was reported that a 25g spinal maxipack needle was broken inside the body of a patient. Surgery was conducted to extract the broken portion of the needle in the patient. No further patient issues reported.
Patient Sequence No: 1, Text Type: D, B5
[56174491]
The spinal maxipack device was returned for evaluation. Examination of stylet with unaided eye found no visible non-conformities but found that it was visibly shorter, about only 45 mm long compared to specification when measured with the calibrated ruler. The fragment of about 45 mm was missing and was not returned for investigation. The outside dimension of returned needle was measured with zygo gauge and the inside dimension of the needle was measured with the pin gauge per incoming documentation. Both parameters were confirmed to be within specification. Additionally the fragment of the returned needle was tested for cannula breakage and no breakage was observed on the needle tubing upon removal from the test fixture. When looked under magnification, the physical appearance of edges on the severed end of the returned component is consistent with bending and breakage. As the returned fragment passed the testing, it is likely that the needle was compromised due to force application by the clinician for undetermined reason after the stylet was removed. The complaint description does not specify the details of the procedure. It is not clear from the complaint information if the stylet was used or introducer needle, which is supplied in the kit to aid the insertion, was utilized during procedure. Based on the evaluation of the returned product and investigation results, the needle breakage was observed however we could not confirm that the customer reported difficulties are relevant to product quality.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183502-2016-01674 |
| MDR Report Key | 5866460 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-08-10 |
| Date of Report | 2016-07-13 |
| Date Mfgr Received | 2016-08-26 |
| Device Manufacturer Date | 2016-03-29 |
| Date Added to Maude | 2016-08-10 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LISA PERZ |
| Manufacturer Street | 1265 GREY FOX RD. |
| Manufacturer City | ST. PAUL MN 51122 |
| Manufacturer Country | US |
| Manufacturer Postal | 51122 |
| Manufacturer Phone | 7633833074 |
| 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 SPINAL ANESTHESIA KIT |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2016-08-10 |
| Returned To Mfg | 2016-07-18 |
| Catalog Number | G973 |
| Lot Number | 3176392 |
| Device Expiration Date | 2019-03-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD INC. |
| Manufacturer Address | 1265 GREY FOX RD. ST. PAUL MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-10 |