MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-06-12 for TECH MEDICAL INSUFFLATION TUBING SET * PMI-102 manufactured by Progressive Medical.
[3557905]
The nurse who was operating the machine noticed there was a leak in the tubing that connected to the insufflation machine. The tubing was replaced and the surgery continued without an issue. At another time following this event tubing from the same lot # box had the same issue; leak in tubing. The box was removed and our hospital will report the issue to the company as well as look to get product replaced. What was the original intended procedure? Laparoscopic cholecystectomy. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3181499 |
| MDR Report Key | 3181499 |
| Date Received | 2013-06-12 |
| Date of Report | 2013-06-12 |
| Date of Event | 2013-05-24 |
| Report Date | 2013-06-12 |
| Date Reported to FDA | 2013-06-12 |
| Date Reported to Mfgr | 2013-06-21 |
| Date Added to Maude | 2013-06-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TECH MEDICAL INSUFFLATION TUBING SET |
| Generic Name | TUBING/TUBING WITH FILTER, INSUFFLATION, LAPAROSCOPIC |
| Product Code | NKC |
| Date Received | 2013-06-12 |
| Model Number | * |
| Catalog Number | PMI-102 |
| Lot Number | 8411205145 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PROGRESSIVE MEDICAL |
| Manufacturer Address | 11085 GRAVOIS INDUSTRIAL COURT SAINT LOUIS MO 63128 US 63128 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-12 |