MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-31 for DESIGN OPTIONS? 530048 manufactured by B. Braun Medical Inc..
[119663225]
(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
[119663226]
As reported by the user facility: customer reports that the clinician was inserting catheter through tuohy needle and met resistance when trying to remove the needle. When removing the catheter through the needle, the catheter sheared. The clinician was able to remove the wire portion of catheter at that time. About six cm of catheter remained in patient. A new spinal one level down was done and after spinal was able to remove the remaining portion of the catheter from patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2018-00065 |
| MDR Report Key | 7837121 |
| Date Received | 2018-08-31 |
| Date of Report | 2018-09-26 |
| Date Mfgr Received | 2018-08-07 |
| Device Manufacturer Date | 2018-03-26 |
| Date Added to Maude | 2018-08-31 |
| 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 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 4847197287 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DESIGN OPTIONS? |
| Generic Name | SPINAL EPIDURAL ANESTHESIA |
| Product Code | OFT |
| Date Received | 2018-08-31 |
| Catalog Number | 530048 |
| Lot Number | 0061605303 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | 901 MARCON BLVD. ALLENTOWN PA 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-08-31 |