MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2017-03-02 for BD VERITOR PHYSICIAN KIT - FLU A & B 256045 manufactured by Becton, Dickinson & Co..
[68772542]
The bd veritor system for rapid detection of flu a+b is a rapid chromatographic immunoassay for the direct and qualitative detection and differentiation of influenza a and b viral nucleoprotein antigens. Nasal and nasopharyngeal swabs of symptomatic patients are tested as an aid in the diagnosis of influenza a and b viral infections. The copan minitip flocked swabs are provided as a component of the veritor flu a+b kits, and are intended to be used for nasopharyngeal or nasal specimen collection. The manufacturing batch history record was examined and showed no discrepant issues related to breakage as observed in the customer complaint. Bd quality performed additional testing of the minitip flocked swabs from retention kits of the same lot and could not replicate the swab tip breakage when used as intended. Quality was unable to confirm the customer complaint and will continue to track and trend. (b)(4). Device returned to manufacturer and evaluated.
Patient Sequence No: 1, Text Type: N, H10
[68772543]
A swab broke during the specimen collection process for a nasal swab specimen from a (b)(6) patient. Approximately 55 mm of the plastic swab shaft and swab tip broke off from the end of the swab. An endoscope was used to examine the paranasal cavity to look for the broken portion of the swab, but was not found. It was later confirmed that the patient ingested the swab as it was found in stool from the patient after the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1119779-2017-00002 |
| MDR Report Key | 6371671 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-01 |
| Date of Event | 2017-02-03 |
| Date Mfgr Received | 2017-02-03 |
| Device Manufacturer Date | 2015-08-12 |
| Date Added to Maude | 2017-03-02 |
| 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 | MEDICAL TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164000 |
| Manufacturer G1 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 21152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VERITOR PHYSICIAN KIT - FLU A & B |
| Generic Name | BD VERITOR SYSTEM FOR RAPID DETECTION OF FLU A+B |
| Product Code | GNX |
| Date Received | 2017-03-02 |
| Catalog Number | 256045 |
| Lot Number | 6282345 |
| Device Expiration Date | 2018-08-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 7 LOVETON CIRCLE SPARKS MD 21152 US 21152 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-02 |