MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-27 for SUREPATH? PRESERVATIVE FLUID COLLECTION VIAL 490527 manufactured by Tripath Imaging, Inc..
[46163578]
Surepath? Preservative fluid is designed for use with the prepstain? System. Surepath? Preservative fluid is an alcohol-based, preservation solution that serves as a transport, preservative and antibacterial medium for gynecologic specimens. Bd quality has investigated the compliant of pap result review with product 490527 surepath? Preservative fluid collection vial. Quality performed a product nonconformance review and determined that all products were within specifications. A complaint history review found zero (0) previous reports for false negatives related to surepath? Preservative fluid collection vial. No return materials were received from the customer. An additional review of the slides by cytologists and pathologists at the customer site confirmed that the slides were negative. This complaint is not confirmed. Quality will continue to track and monitor for trends. Device not returned to manufacturer
Patient Sequence No: 1, Text Type: N, H10
[46163579]
Patient reported with visible lesions but received negative pap and (b)(6) test results. A cervical biopsy was performed resulting in a diagnosis of invasive squamous cell carcinoma. A second (b)(6) test was performed following the biopsy and was also negative. A review of her slide by multiple cytologists and pathologists confirmed it as negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1062336-2016-00002 |
| MDR Report Key | 5686010 |
| Date Received | 2016-05-27 |
| Date of Report | 2016-05-27 |
| Date of Event | 2016-04-30 |
| Date Mfgr Received | 2016-04-30 |
| Date Added to Maude | 2016-05-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX CAROL NIETO |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | TRIPATH IMAGING, INC. |
| Manufacturer Street | 780 PLANTATION DRIVE |
| Manufacturer City | BURLINGTON NC 27215 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27215 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SUREPATH? PRESERVATIVE FLUID COLLECTION VIAL |
| Generic Name | PRESERVATIVE, CYTOLOGICAL |
| Product Code | LEA |
| Date Received | 2016-05-27 |
| Catalog Number | 490527 |
| Lot Number | UNKNOWN |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TRIPATH IMAGING, INC. |
| Manufacturer Address | 780 PLANTATION DRIVE BURLINGTON NC 27215 US 27215 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 2016-05-27 |