MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2011-02-08 for BINAXNOW 416-022 manufactured by Alere Scarborough, Inc..
[15625793]
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, and the doctor noted that the pt sniffed while the sample was being collected. The parents refused any intervention for removal of tip. They were not interested in going to the emergency room. The doctor followed up with the parents on (b)(6) 2011 and (b)(6) 2011 and the child was not uncomfortable and the parents still do not want any further investigations performed on child to retrieve swab tip. The doctor is hoping that the child swallowed the tip and passed it.
Patient Sequence No: 1, Text Type: D, B5
[15848908]
Additional lot# 2363. Additional exp date: 11/30/2014. The nasopharyngeal swab is included as a component of the binaxnow influenza a & b test kit. The swab is a packaged component purchased form (b)(4). Puritan was contacted and informed of this adverse event. The sample was returned to puritan medical products (b)(4), manufacturer of the swab. The following was received from puritan. (b)(4). Batch records were reviewed as well as retention samples pulled for evaluation. No defective or anomalies were discovered. Based on samples examined, shafts do not fracture unless bent repeatedly. It is believed the end user manipulated the swab prior to it entering the nasal passage. (b)(4). It is determined that this is an isolated event given the historical evidence of the claim, the evaluation of the samples. This is an extraordinarily rare incidence.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1221359-2011-00001 |
| MDR Report Key | 1990658 |
| Report Source | 07 |
| Date Received | 2011-02-08 |
| Date of Report | 2011-02-08 |
| Date of Event | 2011-01-10 |
| Date Mfgr Received | 2011-01-10 |
| Date Added to Maude | 2011-02-17 |
| 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 | 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 | 2011-02-08 |
| Returned To Mfg | 2011-01-25 |
| Catalog Number | 416-022 |
| Lot Number | 042827 OR 043170 |
| Device Expiration Date | 2011-10-26 |
| 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. Other | 2011-02-08 |