MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-17 for CARE-FILL CAPILLARY TUBES AT-0006-00-00 manufactured by Epocal, Inc..
[89624931]
Phlebotomist went up to nursery to do epoc cap gas on a baby, started epoc and collected my blood went to start running blood on epoc and it said "qc failed". Collected blood 2nd time went to flip tube up to run on epoc and blood was leaking out the bottom of tube before i could run the sample. I called (b)(4) to see if there was any cap. Tubes down by er and if so to bring them up to me. (b)(4) came up with a tray of tubes and i collected blood for the 3rd time ran it and again the blood was leaking out of the bottom of the tube. I called up to processing and talked to (b)(4) to see if there was a tech that could check and see if there was any trays or cap tubes up there with a different lot number. There wasn't so we tried a different tube from another tray. Finally on the 4th try we got one to work. During all this dr. (b)(6) was standing over my shoulder asking "you have to do it again? " i had explained to her what was happening so she could understand. I had the baby's father and also 3 nurses watching all this happen. I called back upstairs and talked to (b)(4) and a tech to see what to do if another epoc cap gas would be ordered. (b)(4) called the "management on call" and ended up coming to the agreement that doing the old cap gasses and running it upstairs would work. The 2nd time i went up to do another cap gas i talked to dr. (b)(6) about collecting the old way and she said "that would work as long as we don't torment the baby again. " the phlebotomist who reported this is an experienced lab assistant who had collected capillary epoc specimens many times.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072784 |
| MDR Report Key | 6954571 |
| Date Received | 2017-10-17 |
| Date of Report | 2017-10-02 |
| Date of Event | 2017-09-04 |
| Date Added to Maude | 2017-10-17 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CARE-FILL CAPILLARY TUBES |
| Generic Name | EPOC CAPILLARY TUBES |
| Product Code | CGL |
| Date Received | 2017-10-17 |
| Returned To Mfg | 2017-09-29 |
| Catalog Number | AT-0006-00-00 |
| Lot Number | 17013-1 |
| Device Expiration Date | 2018-04-13 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EPOCAL, INC. |
| Manufacturer Address | OTTAWA, ON K1G 3P5 CA K1G 3P5 |
| Brand Name | CARE-FILL CAPILLARY TUBES |
| Generic Name | EPOC CAPILLARY TUBES |
| Product Code | CGL |
| Date Received | 2017-10-17 |
| Catalog Number | AT-0006-00-00 |
| Lot Number | 17013-1 |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | EPOCAL, INC. |
| Brand Name | CARE-FILL CAPILLARY TUBES |
| Generic Name | EPOC CAPILLARY TUBES |
| Product Code | CGL |
| Date Received | 2017-10-17 |
| Catalog Number | AT-0006-00-00 |
| Lot Number | 17013-1 |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | EPOCAL, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-17 |