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 2017-06-29 for ESPOCAN? 333182 manufactured by B. Braun Medical Inc..
[78717474]
(b)(4). Multiple unsuccessful attempts were made to obtain a sample and lot number. Without the actual device and/or lot number, a thorough investigation could not be performed. We will maintain this report for further references and continue to monitor other reports for similar occurrences. If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[78717475]
As reported by the user facility: during the epidural procedure for a low anterior resection where the tip of the perifix 20 gauge closed tip cath broke off into the patient's epidural space. On removal, the black tick mark indicating the tip was not noted to be present. No bleeding was noted at insertion site nor was a remnant of the catheter. A ct scan was ordered and performed shortly afterward. Ct was read by two radiologists who found no evidence of catheter remaining. No injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2017-00102 |
| MDR Report Key | 6677734 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-06 |
| Date of Event | 2017-05-22 |
| Date Mfgr Received | 2017-06-06 |
| Date Added to Maude | 2017-06-29 |
| 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 |
| 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 | 3 |
| Brand Name | ESPOCAN? |
| Generic Name | SPINAL EPIDURAL ANESTHESIA |
| Product Code | OFT |
| Date Received | 2017-06-29 |
| Catalog Number | 333182 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-06-29 |