MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2009-09-23 for SUREPATH COLLECTION KIT 02500-SC manufactured by Coopersurgical, Inc..
[1185926]
An experienced clinician was attempting to break off the spatula into the vial. The spatula would not initially break at the score, even with some force, when it did not break, the liquid containing the specimen splashed into her eye.
Patient Sequence No: 1, Text Type: D, B5
[8365527]
A dhr review was conducted with no anomalies found. Two lots of spatulas were used in the collection kit lot 78027. In-coming inspection records for the two lots were in order. The break test results had acceptable results. The same two lots of lot 78027 were used in four other lots of collection kits without any other similarly reported complaints. The initial reporter provided samples from the same lot (78027). A sample was randomly selected for testing. The tests results showed 6 out 40 with readings out of spec, just greater than 20. 00 n. The out-of-range results were examined finding them to be less than. 4 n from the maximum limit of 20 n. Which to the degree of precision versus working force are indiscernible. This undesirable outcome is being further analyzed at this time to determine whether a more restrictive tolerance is feasible for the material capability. No trend is apparent and no change to design has been made as well as no change to material. It is not known if the clinician was wearing protective eye wear as indicated by the instructions for use. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1216677-2009-00026 |
| MDR Report Key | 1486111 |
| Report Source | 08 |
| Date Received | 2009-09-23 |
| Date of Report | 2009-09-22 |
| Date of Event | 2009-07-22 |
| Date Mfgr Received | 2009-09-02 |
| Device Manufacturer Date | 2009-05-01 |
| Date Added to Maude | 2010-06-08 |
| 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 CYTOLGY COLLECTION DEVICE |
| Product Code | HHT |
| Date Received | 2009-09-23 |
| Model Number | 02500-SC |
| Lot Number | 78027 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2009-09-23 |