MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-24 for APTIMA MULTITEST COLLECTION TUBES PRD-03546 manufactured by Hologic.
[75918929]
(b)(4) did not know the impact of the pileless caps until testing results from 4/24/17. This report is submitted within 30 days from (b)(4) awareness of (b)(6) testing results. Based on those initial results, additional testing was required to determine the final reportability decision.
Patient Sequence No: 1, Text Type: N, H10
[75918930]
The customer, (b)(6), reported an observation of aptima multitest collection tubes that did not contain the cotton layer (pile) within the penetrable cap. The customer continued analysis with specimen tubes from an alternative unaffected lot. Review of the returned items revealed that the lack of a cotton layer is not the result of damage or misuse. The foil seals on the affected tubes returned to site were intact, and when opened the cotton layer was found to be missing. It was concluded that the affected tubes have been manufactured with caps that did not contain the cotton layer. It was determined the incorrect cap (pn 502212) was used to manufacture a small number of mutltitest tubes, pn ffl-00421 ln 184791h.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024800-2017-00016 |
| MDR Report Key | 6589900 |
| Date Received | 2017-05-24 |
| Date of Report | 2017-05-24 |
| Date of Event | 2017-03-24 |
| Date Mfgr Received | 2017-03-24 |
| Date Added to Maude | 2017-05-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. JULIETTE BUSSE |
| Manufacturer Street | 10210 GENECTIC CENTER DR |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal | 92121 |
| Manufacturer Phone | 8584108799 |
| Manufacturer G1 | HOLOGIC, INC. |
| Manufacturer Street | 10210 GENETIC CENTER DR |
| Manufacturer City | SAN DIEGO CA 92121 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92121 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | APTIMA MULTITEST COLLECTION TUBES |
| Generic Name | IN VITRO DIAGNOSTICS |
| Product Code | LSL |
| Date Received | 2017-05-24 |
| Catalog Number | PRD-03546 |
| Lot Number | 185654H |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HOLOGIC |
| Manufacturer Address | 10210 GENETIC CENTER DR SAN DIEGO CA 92121 US 92121 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-24 |