MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,08 report with the FDA on 2007-06-01 for SUREPATH COLLECTIONS VIAL COLLECTION VIAL manufactured by Tripath Imaging, Inc..
[662219]
On 05/08/07, tripath imaging rec'd a report from our distributor that an accident occurred while a health care professional was handling a pt collection vial normally associated with surepath/prepstain device. A technician in the laboratory at university removed the lid of the vial and extracted 100 ul using a plastic pipette. The sample was transferred in the fume hood, but as the pipette was being discarded into the waste bucket, the pipette tip caught the edge of the fume hood causing the pipette bundle to bend and spray its residual contents into the technician's eye. Safety goggles had not been worn. The technician then washed her eye using a saline eyewash and has suffered no ill effects. The collection vial was the only component involved; no other part of the surepath/prepstain device was used in this incident. The preservative fluid has been shown to be viricidal to hiv, hbv and hcv. Hpv has never been tested in this preservative fluid because it cannot be cultured. We make no claims concerning viruses.
Patient Sequence No: 1, Text Type: D, B5
[7871275]
A researcher at university was using a surepath collection vial off label for a research study. They had obtained the vials from another lab and were not trained users on the surepath process. No other surepath or prepstain device was involved in this incident. The researcher was pipetting some sample from the vial into a tube when she accidently caused some residual fluid from the pipette tip to be sprayed into her unprotected eye. The amount was only micro-droplets. The sample, however, contained alcohols, formaldehyde and hpv virus. The eye was irrigated with saline solution per instructions on our labeling but not other medical actions are being taken. This was clearly an accident and user error; there was no device malfunction. Decision to file was based on co sops and the possibility of potential problems with this pt relevant to either the preservative solution or the hpv in her eye.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062336-2007-00001 |
| MDR Report Key | 859466 |
| Report Source | 01,05,08 |
| Date Received | 2007-06-01 |
| Date of Report | 2007-05-31 |
| Date of Event | 2007-05-08 |
| Date Mfgr Received | 2007-05-08 |
| Date Added to Maude | 2007-09-17 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | KENNETH EDDS, SR DIRECTOR |
| Manufacturer Street | 780 PLANTATION DR. |
| Manufacturer City | BURLINGTON NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9192067140 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUREPATH COLLECTIONS VIAL |
| Generic Name | CERVICAL CYTOLOGY COLLECTION VIAL |
| Product Code | LEA |
| Date Received | 2007-06-01 |
| Model Number | COLLECTION VIAL |
| Catalog Number | SUREPATH |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 884792 |
| Manufacturer | TRIPATH IMAGING, INC. |
| Manufacturer Address | 780 PLANTATION DR. BURLINGTON NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-06-01 |