MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-01-05 for BINAXNOW 416-022 manufactured by Alere Scarborough, Inc..
[1775954]
When collection a nasopharyngeal sample for the binaxnow influenza a&b test kit, the plastic shaft of the collection swab provided in the kit broke where the foam and shaft meet. The plastic shaft and foam were lodged in the pt's nasal passage. The pt was referred to an ear, nose and throat (ent) specialist for removal of the swab tip. Customer was unable to provide swab or kit lot number. Per the user site, the available swabs are swab lots 2360 and 2378. Both of these lots have an expiration date of 11/30/2014. The kit numbers on site are 042827 and 043170. Per the reporting site, the tip was successfully removed by the ent.
Patient Sequence No: 1, Text Type: D, B5
[8868430]
The nasopharyngeal swab is included as a component of the binaxnow influenza a&b test kit. The swab is a packaged component purchased from puritan medical products, llc, (b)(4). Puritan was contacted and informed of this adverse event. The sample was returned to puritan medical products co llc, manufacturer of the swab. The following was received from puritan. Lots 2360 and 2378 represent a total of 540,000 cases of applicators produced in (b)(6) 2009. Puritan examined records and product retention samples. No anomalies were found. The returned samples were examined and shafts do not fracture unless bent several times. It should be noted that the shaft material which is the subject of this claim has been changed from polystyrene to acetal which is a fracture resistant material. It is determined that this is an isolated event given the historical evidence of the claim, the eval of the samples. This is an extraordinarily rare incidence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221359-2010-00002 |
| MDR Report Key | 1956638 |
| Report Source | 07 |
| Date Received | 2011-01-05 |
| Date of Report | 2011-01-05 |
| Date of Event | 2010-12-06 |
| Date Mfgr Received | 2010-12-06 |
| Date Added to Maude | 2011-01-14 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | EMILY DEANE, MGR |
| Manufacturer Street | 10 SOUTHGATE RD |
| Manufacturer City | SCARBOROUGH ME 04074 |
| Manufacturer Country | US |
| Manufacturer Postal | 04074 |
| Manufacturer Phone | 2077305750 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BINAXNOW |
| Generic Name | INFLUENZA A&B CLIA WAIVED 22 TEST KIT |
| Product Code | GNX |
| Date Received | 2011-01-05 |
| Returned To Mfg | 2010-12-09 |
| Catalog Number | 416-022 |
| Lot Number | 042827 OR 043170 |
| Device Expiration Date | 2011-10-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALERE SCARBOROUGH, INC. |
| Manufacturer Address | SCARBOROUGH ME US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-01-05 |