MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-13 for PENCAN BUPIVACAINE AND DEXTROSE manufactured by Hospira.
[73234873]
Product did not work that was in a kit called pencan spinal tray ref (b)(4), product code p24bk lot: 00611545666 exp 05/31/2018. The product is bupivacaine 0. 75% in dextrose 8. 25% 2ml amp. Lot: 430703a, exp: 07/01/2017. Anesthesiologist pulled same product from pharmacy stock bupivacaine 0. 75% with dextrose 8. 25% 2ml amp lot: 662603a exp 06/01/2019 and it did not work either. He stated product in kits has failed 5x in last 2 months. I do not have the lot # nor the exp date for the previous patients. All patients had spinal procedures with bupivacaine 0. 75% with dextrose 8. 25% 2ml from the pencan spinal tray.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069157 |
| MDR Report Key | 6499951 |
| Date Received | 2017-04-13 |
| Date of Report | 2017-04-13 |
| Date of Event | 2017-04-13 |
| Date Added to Maude | 2017-04-18 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PENCAN BUPIVACAINE AND DEXTROSE |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2017-04-13 |
| Lot Number | 00611545666 |
| Device Expiration Date | 2018-05-31 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA |
| Brand Name | PENCAN BUPIVACAINE AND DEXTROSE |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2017-04-13 |
| Lot Number | 430703 |
| Device Expiration Date | 2017-07-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA |
| Brand Name | PENCAN BUPIVACAINE AND DEXTROSE |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2017-04-13 |
| Lot Number | 662603 |
| Device Expiration Date | 2019-06-01 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA |
| Brand Name | PENCAN BUPIVACAINE AND DEXTROSE |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2017-04-13 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 4 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA |
| Brand Name | PENCAN BUPIVACAINE AND DEXTROSE |
| Generic Name | SPINAL ANESTHESIA KIT |
| Product Code | OFU |
| Date Received | 2017-04-13 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 5 |
| Device Event Key | 0 |
| Manufacturer | HOSPIRA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-13 |