MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-22 for PENCAN 333851 manufactured by B. Braun Medical Inc..
[83216611]
Patient Sequence No: 1, Text Type: N, H10
[83216612]
Spinal anesthetic was not effective. Doctor is certain meds were injected into proper place, yet numbness wasn't felt by patient. Doctor states meds from spinal kit were defective. This is the email i got from the clinical coordinator of (b)(6): we have had two physicians complain of failed spinals from lot listed below. This time they are probably getting too hot? The temp range on package is 68-77? F. I have removed the kits from inpatient anesthesia w/ lot # 0061558594, obstetrics was working on removing them from their department. I will call the rep from braun. They are b# 24630. There are 12-15 kits in my office. I contacted medical affairs at braun like i was instructed from (b)(4). When i spoke to them they said they did not except any product back because the drug company did not take them back. I told her i was instructed to contact medical affairs to send the product back. She also stated that this does happen with the change of the weather. I asked her how does she know that's what is wrong with them when they do not get tested. Again i told her i was instructed to send them back. She put me on hold and came back to the phone and said that our facility was the only place that was able to send them back.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6809646 |
| MDR Report Key | 6809646 |
| Date Received | 2017-08-22 |
| Date of Report | 2017-08-16 |
| Date of Event | 2017-08-11 |
| Report Date | 2017-08-16 |
| Date Reported to FDA | 2017-08-16 |
| Date Reported to Mfgr | 2017-08-16 |
| Date Added to Maude | 2017-08-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 | 2017-08-22 |
| Model Number | 333851 |
| Catalog Number | 333851 |
| Lot Number | 0061558594 |
| Device Expiration Date | 2018-08-31 |
| Device Availability | * |
| Device Age | 4 MO |
| 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 | 2017-08-22 |