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 2017-04-06 for DESIGN OPTIONS? 530083 manufactured by B. Braun Medical, Inc..
[72339003]
This report has been identified as b. Braun medical inc. Internal report number (b)(4), event #1. 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. No sample available to evaluate.
Patient Sequence No: 1, Text Type: N, H10
[72339004]
As reported by the user facility: event #1: tip of the epidural catheter broke off in the patient. Tip remains inside patient. No follow up care was given to patient. No side effects from the tip breaking off. No retrieval was attempted. It was stated there was resistance felt when attempting to remove the catheter but they continued to pull.
Patient Sequence No: 1, Text Type: D, B5
[76640621]
This report has been identified as b. Braun medical inc. (b)(4). The actual device involved in the reported incident was not returned for evaluation. Without the actual sample a thorough sample analysis could not be performed and no specific conclusions can be drawn. If additional pertinent information becomes available a follow-up report will be filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2017-00043 |
| MDR Report Key | 6463482 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-04-06 |
| Date of Report | 2017-03-15 |
| Date of Event | 2017-03-08 |
| Date Mfgr Received | 2017-03-15 |
| Date Added to Maude | 2017-04-06 |
| 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 | JONATHAN SEVERINO |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DESIGN OPTIONS? |
| Generic Name | SPINAL EPIDURAL ANESTHESIA |
| Product Code | OFT |
| Date Received | 2017-04-06 |
| Model Number | 530083 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2017-04-06 |