MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2008-05-09 for SUREPATH COLLECTION KIT 02500-SC manufactured by Coopersurgical, Inc..
[847864]
The facility reported to their clinical laboratory services provider, 3 instances of clinic personnel being splashed in the eye with surepath preservative fluid with pap sample. The events occurred 2 times in 2008. In each case, the practitioner was attempting to remove the head of the collection spatula when the sample was splashed. They stated that it was "difficult" to remove the head of the collection device. Clinic personnel were not wearing recommended personal protective equipment. The samples were not known to be positive for any infectious agent, however all exposed personnel were treated with prophylaxis medications as a precaution and will be monitored for 3-6 months per clinic policy. Reference mw# 1062336-2008-00004.
Patient Sequence No: 1, Text Type: D, B5
[8063258]
Additional lot # 57149. Subject lot 57148 was produced in august 2007. Subject lot 57149 was produced in october 2007. Coopersurgical produces this product. Coopersurgical was informed of this event via letter dated march 21, 2008 and we are reporting also at this time as we are in receipt of mdr# 1062336-2008-00004. Reporter had indicated the clinician was not using the spatula in one of the three recommended techniques. The clinician was not wearing any protective eye wear as recommended. The reporter has retrained the clinicians.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2008-00013 |
| MDR Report Key | 1040932 |
| Report Source | 08 |
| Date Received | 2008-05-09 |
| Date of Report | 2008-05-08 |
| Date of Event | 2008-03-10 |
| Date Mfgr Received | 2008-04-01 |
| Date Added to Maude | 2008-09-19 |
| 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 | THOMAS WILLIAMS |
| Manufacturer Street | 95 CORPORATE DR. |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| 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 | 2008-05-09 |
| Model Number | 02500-SC |
| Lot Number | 57148/57149 |
| 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 | 1036592 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | TRUMBULL CT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2008-05-09 |