MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-28 for CLEAR-CRIT PLASTIC CAPILLARY TUBES 270-106 manufactured by Separation Technology, Inc..
[185146]
A fingerstick puncture was performed on a potential blood donor. A sample of blood was to be obtained to determine the donor's hematocrit. The capillary tubes did not appear to fill with blood in a routine manner. The hematocrit value obtained for the donor was only 24%. Further investigation revealed that the inside diameter(id) of the capillary tubes in the sleeves(vials) was only 0. 5mm instead of 1. 1mm. The vials were labeled as containing 1. 1mm(id) tubes. Another hematocrit determination was performed on the donor with 1. 1mm(id) tubes and the result obtained was 37% as compared to the previous result of 24%. Rptr retrieved 8 boxes of capillary tubes(200 tubes/vial) and each box had 1 vial of tubes, 0. 5mm(id) and the vial was labeled as containing 1. 1mm(id) tubes. All other vials contained tubes 1. 1(id) in appropriately labeled vials. The mfr was notified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1017436 |
| MDR Report Key | 247147 |
| Date Received | 1999-10-28 |
| Date of Report | 1999-10-28 |
| Date of Event | 1999-10-06 |
| Date Added to Maude | 1999-11-02 |
| 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 | 0 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CLEAR-CRIT PLASTIC CAPILLARY TUBES |
| Generic Name | CAPILLARY TUBES |
| Product Code | GIO |
| Date Received | 1999-10-28 |
| Model Number | NA |
| Catalog Number | 270-106 |
| Lot Number | 11208-06079-1239 |
| ID Number | * |
| Device Expiration Date | 2001-06-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 239425 |
| Manufacturer | SEPARATION TECHNOLOGY, INC. |
| Manufacturer Address | 1096 RAINER DRIVE ALTAMONTE SPRINGS FL 327143846 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1999-10-28 |