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 2018-08-16 for PENCAN? 333858 manufactured by B. Braun Medical Inc..
[117420451]
This report has been identified as b. Braun medical internal report number (b)(4). Although it was confirmed that the device is not available for further evaluation, 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
[117420452]
As reported by the user facility: problem: end user states that during a procedure the patient (male) received an uneventful/uncomplicated spinal and during insertion the needle broke off. An attempt was made to excise the broken piece without success. Patient was scanned and it was confirmed the patient had retained the piece in soft tissue. The patient did not have any affects. Patient was referred to neurosurgeon for follow up customer to confirm if the patient had surgery delayed or not. It was confirm that the patients procedure was aborted due to the defect. The patient was asymptomatic; however was referred to neurosurgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523676-2018-00063 |
| MDR Report Key | 7791876 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-08-16 |
| Date of Report | 2018-09-26 |
| Date of Event | 2018-07-09 |
| Date Mfgr Received | 2018-08-02 |
| Device Manufacturer Date | 2018-04-09 |
| Date Added to Maude | 2018-08-16 |
| 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 | PENCAN? |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2018-08-16 |
| Catalog Number | 333858 |
| Lot Number | 0061607899 |
| 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 | 1. Required No Informationntervention | 2018-08-16 |