MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-02-04 for DESIGN OPTIONS? 552006 manufactured by B. Braun Medical Inc..
[177973164]
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
[177973165]
As reported by the user facility: complaint report states that a 30 gage hypodermic needle broke off from the hub in the patient. Details of the incident, the clinician cleaned the patient's back and administered the local anesthetic (skin wheal). Upon removing the syringe, she noticed that the needle had broken off the hub of the syringe and remained in the patient's back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2020-00009 |
| MDR Report Key | 9665126 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-02-04 |
| Date of Report | 2020-02-26 |
| Date of Event | 2020-01-09 |
| Date Mfgr Received | 2020-01-09 |
| Device Manufacturer Date | 2019-08-12 |
| Date Added to Maude | 2020-02-04 |
| 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 | 3 |
| Brand Name | DESIGN OPTIONS? |
| Generic Name | EPIDURAL ANESTHESIA KIT |
| Product Code | OGE |
| Date Received | 2020-02-04 |
| Returned To Mfg | 2020-01-29 |
| Model Number | 552006 |
| Catalog Number | 552006 |
| Lot Number | 0061686324 |
| 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 18109 US 18109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |