MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,08 report with the FDA on 2010-05-20 for SUREPATH COLLECTION KIT 02500-SC manufactured by Coopersurgical, Inc..
[1552244]
Bd tripath physician sales representative (b) (4) reported an incident in a doctor's office on (b) (6) 2010, where a medical assistant (b) (4) splashed bd surepath preservative fluid in her eye after having difficulty breaking off the head of the spatula while placing it in the bd surepath specimen vial. The medical assistant was seen in the er at (b) (6) medical center in (b) (6). The medical assistant was not wearing eye protection. In this case, the medical assistant was attempting to remove the head of the collection spatula when the sample was splashed. The medical assistant stated that it was "difficult" to remove the head of the collection device.
Patient Sequence No: 1, Text Type: D, B5
[8657344]
Cooper surgical produces this product for bd tripath. Upon receipt of the incident, cooper surgical was notified of the event. The clinician was not wearing any protective eye wear as recommended. Initial test results of the splashed specimen collected showed positive for chlamydia. Pt has been advised to follow up with employer and physician. Blood work will be analyzed after six months. Clinic will provide an update if abnormal results are returned from the blood work. As new info is received an update/follow will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1062336-2010-00006 |
| MDR Report Key | 1696668 |
| Report Source | 05,06,08 |
| Date Received | 2010-05-20 |
| Date of Report | 2010-01-01 |
| Date of Event | 2010-04-23 |
| Date Mfgr Received | 2010-04-23 |
| Date Added to Maude | 2010-05-26 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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. SUITE 400 |
| Manufacturer City | DURHAM 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 COLLECTION KIT |
| Generic Name | CERVICAL CYTOLOGY SAMPLING KIT |
| Product Code | HHT |
| Date Received | 2010-05-20 |
| Model Number | 02500-SC |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-05-20 |