MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-12 for DOT,4FR POWERMIDLINE N/A P4154108D manufactured by Bard Access Systems.
[183179171]
The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) of redx3829 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[183179173]
It was reported that the midline introducer was more flimsy than usual and as a result, when the nurse tried to enter it into the patient? S skin, it? Mushroomed.? It caused pain to the patient and they were not able to insert the introducer into the skin as a result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00843 |
| MDR Report Key | 9826155 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-21 |
| Device Manufacturer Date | 2019-10-01 |
| Date Added to Maude | 2020-03-12 |
| 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 | DOT,4FR POWERMIDLINE |
| Generic Name | MIDLINE CATHETER |
| Product Code | PND |
| Date Received | 2020-03-12 |
| Model Number | N/A |
| Catalog Number | P4154108D |
| Lot Number | REDX3829 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2020-03-12 |