MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-27 for SILICONE CATHETERS STRAIGHT 14028 manufactured by .
[181619065]
A follow up report will be submitted upon completion of the investigation into this event. Device not returned.
Patient Sequence No: 1, Text Type: N, H10
[181619066]
Report received stated that one physician cuts the tip of the catheter before use and has reporting tearing of the catheter.
Patient Sequence No: 1, Text Type: D, B5
[188146042]
Analysis - based on the details of the complaint the clinician was cutting the catheter prior to use then had claimed that the catheter was tearing. Based on the instructions for use, the? Warnings section advises the following:? Warning care should be taken during catheter insertion, fixation and removal to avoid accidental or intensional cutting, suturing to or puncturing of the thoracic catheter as this may result in tearing of the catheter, causing device failure, patient injury or death?. As no lot number was provided an evaluation of the device history records could not be conducted atrium medical corporation only releases product that has met all quality requirements.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3011175548-2020-00328 |
| MDR Report Key | 9767122 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-14 |
| Date Mfgr Received | 2020-02-14 |
| Date Added to Maude | 2020-02-27 |
| 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 | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal | 03054 |
| Manufacturer G1 | ATRIUM MEDICAL CORPORATION |
| Manufacturer Street | 40 CONTINENTAL BLVD |
| Manufacturer City | MERRIMACK NH 03054 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03054 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SILICONE CATHETERS STRAIGHT |
| Generic Name | CATHETER, CHOLANGIOGRAPHY |
| Product Code | GBZ |
| Date Received | 2020-02-27 |
| Model Number | 14028 |
| Catalog Number | 14028 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-27 |