MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,user f report with the FDA on 2020-03-25 for POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER) N/A S1274108D4 manufactured by Bard Access Systems.
[186604206]
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of redp4989 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[186604207]
It was reported picc services was consulted on (b)(6) 2020 on a patient in the ed. Picc was consulted as pt has a long history of abscesses with long term abx therapy. Patient has a lue dvt so a rue picc was placed. A 4 french double lumen picc was inserted to the basilic vein without difficulty. A portable cxr was ordered due to inability to obtain ecg reading. Upon visualization of cxr picc line was in expected position but there was a questionable object noted. The patient was checked to make sure nothing was on her body and repeat cxr was ordered. The repeat file showed same questionable object and the picc line was folded up. Informed pt nurse not to use picc line at this time. The guide wire and the magnet wire was retrieved for inspection. A 3. 5 cm of stylet wire was broken off and later retrieved from inside the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-01056 |
| MDR Report Key | 9880968 |
| Report Source | COMPANY REPRESENTATIVE,USER F |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date Mfgr Received | 2020-03-06 |
| Device Manufacturer Date | 2019-02-01 |
| Date Added to Maude | 2020-03-25 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POWERPICC PROVENA 4F DL MBPLUS (3CG, BIOPATCH, PROBE COVER) |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS |
| Product Code | LJS |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-09 |
| Model Number | N/A |
| Catalog Number | S1274108D4 |
| Lot Number | REDP4989 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-25 |