MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-18 for CONTIPLEX? 331641 manufactured by B. Braun Medical Inc..
[180420010]
This report has been identified as b. Braun medical internal report number (b)(4). The device involved has not been received for evaluation and the investigation is ongoing at this time. A follow up will be submitted when the investigation results become available.
Patient Sequence No: 1, Text Type: N, H10
[180420011]
As reported by the user facility: description of issue: on (b)(6) 2020, patient received a femoral nerve block. On (b)(6) 2020, the catheter was removed and 1 cm of the blue tip was noted to be missing. It appeared that the tip was sheared off. An x-ray was done and no catheter was seen. No redness, tenderness, swelling was noted at the site. Surgeon was consulted and it was recommended to monitor the site. No additional treatments were performed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2020-00012 |
| MDR Report Key | 9720667 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-18 |
| Date of Report | 2020-03-24 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-04 |
| Date Added to Maude | 2020-02-18 |
| 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 | MR. JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN, PA |
| Manufacturer Country | US |
| Manufacturer Phone | 7197287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTIPLEX? |
| Generic Name | NERVE BLOCK TRAY (KIT) |
| Product Code | OGJ |
| Date Received | 2020-02-18 |
| Returned To Mfg | 2020-03-06 |
| Model Number | 331641 |
| Catalog Number | 331641 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN, PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-18 |