MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-25 for BARD POWER PICC (3 LUMEN) CATHETER W/ SHERLOCK 3CG TM TIP manufactured by Bard Access Systems, Inc..
[185222287]
Flushed lumen (grey) of picc line, flushing pressure appeared to have a ruptured picc line: vessel was intact. Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093926 |
| MDR Report Key | 9882847 |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-03-18 |
| Date Added to Maude | 2020-03-26 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHYSICIAN ASSISTANT |
| 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 | BARD POWER PICC (3 LUMEN) CATHETER W/ SHERLOCK 3CG TM TIP |
| Generic Name | CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS |
| Product Code | LJS |
| Date Received | 2020-03-25 |
| Lot Number | REDS2389 |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Product Code | --- |
| Date Received | 2020-03-25 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |