MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-07-30 for FLOQSWABS 503CS01 manufactured by Copan Flock Technologies.
[3622267]
A nasopharyngeal swab broke off at the transition point where the shaft changes from thin to thick in (b)(6) on (b)(6) at pediatrics. Two nurses were there for the incident, one was performing nasopharyngeal collection while the other was holding the child laying in the supine position. Swab was rotated multiple times [during a song of the abc's - in which the nurse reached the end of the alphabet but had not yet finished the song] for a total of 10 seconds before the nurse felt the give in the swab - indicating the break. The child was crying, but not thrashing. When the swab broke, the end still inside the pt was not visible. It is indicated in the documentation from the ed that the child jerked and that is when the swab broke. After the incident, the child did not cough, gag, or appear to be distressed in any way. As of (b)(6), the mother confirmed that the child had not coughed out the swab or passed it in her stool. Pt had a f/u appointment on (b)(6) but it was an already scheduled appointment and was not in regards to the swab incident.
Patient Sequence No: 1, Text Type: D, B5
[10977625]
Mfr investigation report: our original complaint investigation could not confirm any malfunction or defect in the device lot associated with this incident. The dhr was reviewed and no anomalies have been found during all the production steps.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005477219-2013-00001 |
| MDR Report Key | 3264014 |
| Report Source | 08 |
| Date Received | 2013-07-30 |
| Date of Report | 2013-06-05 |
| Date of Event | 2013-05-29 |
| Date Mfgr Received | 2013-06-05 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2013-08-06 |
| 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 Street | VIA PEROTTI 16-18 |
| Manufacturer City | BRESCIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 302687212 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOQSWABS |
| Product Code | KXG |
| Date Received | 2013-07-30 |
| Model Number | 503CS01 |
| Catalog Number | 503CS01 |
| Lot Number | I60U00 |
| Device Expiration Date | 2016-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN FLOCK TECHNOLOGIES |
| Manufacturer Address | VIA PEROTTI 16-18 BRESCIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2013-07-30 |