MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-01 for MEDLINE INDUSTRIES, ANGIO PACK DYNJ38846 manufactured by Medline Industries, Inc..
[137513234]
During a diagnostic cardiac catheterization, cardiologist used the safety scalpel from the angiography pack to nick the skin prior to inserting the sheath for the procedure. When cardiologist pressed the scalpel to retract the blade, the blade few out the back and onto the floor between 2 members of the surgical team. No injury noted to staff. Manufacturer response for angiography pack, scalpel no. 11 safety (per site reporter). Equipment failure reported to medline industries customer service rep. Complaint notification number (b)(4). Product available for return to manufacturer. Product to be returned.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8381450 |
| MDR Report Key | 8381450 |
| Date Received | 2019-03-01 |
| Date of Report | 2019-02-21 |
| Date of Event | 2019-02-06 |
| Report Date | 2019-02-26 |
| Date Reported to FDA | 2019-02-26 |
| Date Reported to Mfgr | 2019-03-01 |
| Date Added to Maude | 2019-03-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDLINE INDUSTRIES, ANGIO PACK |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2019-03-01 |
| Model Number | DYNJ38846 |
| Catalog Number | DYNJ38846 |
| Lot Number | 18KDC327 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-01 |