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 2017-03-07 for CNO11, GELPOINT PATH 5.5CM 15 manufactured by Applied Medical Resources.
[69328711]
The event unit was returned to applied medical for evaluation. Upon inspection, engineering confirmed the customer experience that one sleeve had separated from its septum. A review of the manufacturing records for the lot number provided revealed that the product passed all quality and manufacturing inspections. The root cause of the separated septum is the swab being pushed through. It is likely the swab was not lubricated and the highly textured surface of the material would cause enough friction to push the septum out of the sleeve. If an aggressive angle was used to insert and remove the swab this could have contributed to the septum separation. The instructions for use caution ""to minimize eversion of the sleeves seal, instruments with high textured surfaces should be coated with a sterile lubricant. " in addition, "all instruments should be centered axially when inserted through the sleeves seal for easier insertion. " this report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016. This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter. Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes. The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies). This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review. In accordance to 21 cfr 803. 56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Patient Sequence No: 1, Text Type: N, H10
[69328712]
Tamis- "surgeon put a little swap through. Swap pulled of the seal. It was torn off. Swap was stuck on the seal. " patient status - "patient is ok".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2017-01490 |
| MDR Report Key | 6385922 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-03-07 |
| Date of Report | 2017-03-07 |
| Date of Event | 2015-02-25 |
| Date Mfgr Received | 2015-02-25 |
| Device Manufacturer Date | 2014-04-01 |
| Date Added to Maude | 2017-03-07 |
| 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 Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138233 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CNO11, GELPOINT PATH 5.5CM |
| Generic Name | FER |
| Product Code | FER |
| Date Received | 2017-03-07 |
| Returned To Mfg | 2015-03-19 |
| Model Number | 15 |
| Catalog Number | 15 |
| Lot Number | 1221910 |
| Device Expiration Date | 2017-04-29 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 5 | 2017-03-07 |