MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-28 for DISPOSABLE TECA CONCENTRIC NEEDLE S53153 manufactured by Natus Manufacturing Limited.
[26870694]
Registered internally as a complaint ((b)(4)) for investigation purposes. Needle in route to natus for investigation. For this event, the doctor noticed the needle separation and did not prick herself. The device history record for (b)(4) lot 08a/15/tg was obtained and reviewed. In process testing and inspections were reviewed. All samples taken for tests gave acceptable result. No issues were noted. All checks were completed as required by the process and quality plan for the concentric needle. No excessive scrap quantities were noted. No rework or sort performed on this lot. No ncr's noted for this lot. The customer complaints log was reviewed for the last 12 months and no other complaint for this issue have arisen. Retains from this batch were requested and received.
Patient Sequence No: 1, Text Type: N, H10
[26870695]
Customer reported that after the first needle insertion, the user puts the "used" needle back into the needle sheath which is held by an emg needle holder near the machine. When they take the needle back out of the sheath to use again on the patient, the needle is detaching from the red hub. Gurvarinder says they have used our needles for a very long time. They have three bad needles from the same box that this has occurred. She feels this is a safety issue.
Patient Sequence No: 1, Text Type: D, B5
[59982696]
The following has been corrected: date of this report - corrected to 07/28/2015 (when reported to company) from 08/31/2015 device evaluated by manufacturer? - corrected from ''no: device evaluation anticipated, but not yet begun'' to ''device not returned for evaluation''.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005581270-2015-00004 |
| MDR Report Key | 5107353 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-28 |
| Date of Report | 2015-07-28 |
| Date of Event | 2015-07-16 |
| Date Mfgr Received | 2015-07-30 |
| Device Manufacturer Date | 2015-02-16 |
| Date Added to Maude | 2015-09-28 |
| 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 | MR MICHAEL GALVIN |
| Manufacturer Street | IDA BUSINESS PARK GORT, CO, GALWAY |
| Manufacturer City | GALWAY, CONNAUGHT H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal | H91PD92 |
| Manufacturer Phone | 9164700 |
| Manufacturer G1 | NATUS MANUFACTURING LIMITED |
| Manufacturer Street | IDA BUSINESS PARK N/A |
| Manufacturer City | GORT, CO. GALWAY H91PD92 |
| Manufacturer Country | EI |
| Manufacturer Postal Code | H91PD92 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE TECA CONCENTRIC NEEDLE |
| Generic Name | ELECTRODE |
| Product Code | GXZ |
| Date Received | 2015-09-28 |
| Model Number | S53153 |
| Catalog Number | S53153 |
| Lot Number | 08A/15/TG |
| Device Expiration Date | 2018-02-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NATUS MANUFACTURING LIMITED |
| Manufacturer Address | IDA BUSINESS PARK, GORT, CO. GALWAY GALWAY, CONNAUGHT H91PD92 EI H91PD92 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-09-28 |