MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-25 for POWERPICC SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI N/A 9295108D manufactured by Bard Access Systems.
[187597403]
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Patient Sequence No: 1, Text Type: N, H10
[187597404]
It was reported "picc extravasation". Additional information received 03/18/2020: "on (b)(6) 2020, the patient underwent a cta of the chest. Approximately 50 mls of the contrast, which was being delivered via the picc line, extravasated within the mediastinum and into the right pleural space suggesting a defect or perforation of the superior vena cava. At the present time the main concern in this patient is the fact that she has extravasation of dye into the mediastinum which is concerning for an svc perforation secondary to the picc line. Dr. Has requested a ct of the chest to be obtained stat to rule out any development of any hematoma. As long as patient is hemodynamically stable and no evidence of any hematoma or any worsening leakage dr. Will be planning on possibly removing the picc line tomorrow morning under controlled circumstances in the cath lab. In the meantime, the picc line is to remain in place and not be used. We will try to place peripheral iv access today. Patient will be transferred to the intensive care unit. The duoneb will be discontinued and will start her on atrovent. I will discontinue the amiodarone and put her on amiodarone drip with a bolus again. An echocardiogram has already been requested and is pending. I will start on a lasix drip and monitor electrolytes appropriately. I would keep her n. P. O. Except for medications and sips of water and keep of the head of the bed elevated i will discontinue all types of anticoagulation and put her on dvt prophylaxis via mechanical prophylaxis. (b)(6)-year-old woman who was initially admitted 10 days ago for a total abdominal hysterectomy. She did well and was discharged home last thursday only to be readmitted on friday with bowel obstruction secondary to an incarcerated hernia which did not decompress on its own. She underwent surgical correction and decompression last saturday. Her hospital course was complicated by paroxysmal atrial fibrillation with rapid ventricular rate which initially was placed on amiodarone drip and then switched to amiodarone p. O. And has been relatively stable. She has been on continuous iv fluid hydration and according to patient she has gained close to 30 pounds since her admission. He has developed massive leg edema had progressive dyspnea on exertion. Fluids were stopped today and the patient was started on lasix. With some clinical response. Due to her dyspnea ct of the chest was obtained which revealed bilateral pleural effusions a large one on the right and is small to medium 1 on the left. There was also evidence of extravasation of dye from the svc into the superior anterior mediastinum. Patient kept on going in and out of a. Fib and was good for consultation. Patient denies any prior history of any heart disease except for occasional pvcs for which she sees dr. Patient reports no signs of any prior lung disease. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-01021 |
| MDR Report Key | 9879206 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-25 |
| Date of Event | 2020-02-01 |
| Date Mfgr Received | 2020-03-03 |
| 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 | KAYLA OLSEN |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225010 |
| 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 SOLO2 CATHETER WITH SHERLOCK TLS TECHNOLOGY 5F MAXIMAL BARRIER TRAY WI |
| Generic Name | CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS |
| Product Code | LJS |
| Date Received | 2020-03-25 |
| Returned To Mfg | 2020-03-19 |
| Model Number | N/A |
| Catalog Number | 9295108D |
| Lot Number | UNK |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-25 |