MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-11-20 for COPAN TRANSYSTEM AMIES MEDIUM WITH CHARCOAL 114C.USE manufactured by Copan Italia Spa.
[5227681]
The event occurred in (b)(6). The verbal report from the physician provided by the medical laboratory indicates that "child was examined sitting beside mother in chair. Flashlight exam noted throat slightly red; stuffy nose. Decision made to check for strept using laboratory swab, child appeared well; sitting in the chair; completely cooperative. Child did not struggle; no need to hold. Physician removed stick from package as per normal practice; swabs are stored on counter in bucket. Inserted into mouth; no tongue depressor used. Swabbed left tonsil. Removed stick; turned to grab package to insert stick into tube: realized no tip was stick. Turned back to child who remained completely stable. Asked child "are you ok" and he said "yes. " patient didn't report anything. When asked "did you swallow it? " he was confused by question and replied "maybe. " physician immediately questioned herself re: what happened to the tip? Did we lose it? Did he swallow it? Listened to patient's chest - clear. Patient continued to breath and talk normally; sat happily. Mom was not distressed. Physician explained situation to mom; both looked around clothing and area and in package: not found. Physician grabbed another swab to determine size of missing tip. Determined it was cotton and piece of shaft. Physician spoke to mom re: risks of swallowing foreign body. Decision made to send patient to (b)(6) with explanatory note. Mom took swab with her to emergency department. Prior to leaving office, completed a quick strept test - patient remained completely cooperative. Quick strept negative. Physician apologised to mom; acknowledged that incident would be reported. Provided mom with physician's cell phone number and requested that mom return the swab. Then call (b)(4) to report incident. Patient was seen at (b)(6); x-ray done; no concerns noted. Mom remains in touch with physician.
Patient Sequence No: 1, Text Type: D, B5
[12521590]
Analysis of batch history records: copan checked the internal records related to the controls made before the release on the market on the swabs of the product code 114c. Use number pcx801: lot reported in the incident met manufacturing specifications. The original lot, manufactured 2013, was comprised of (b)(4) units, this is the first notification received for this specific lot. The device was not returned to copan for evaluation. Mechanical test on the retained sample from the claimed lot has been performed: all the tested swabs gave conforming results. Our investigation could not confirm any malfunctions or defects in the device lot associated with this incident. We are unable to determine a root cause for the reported event. However, based on: the medical description of the event, the patient behavior after the event and the internal investigation on the retained samples, our hypothesis is that the tip was already missing before the swab was used for sampling. A review of past complaints for this product does not indicate a trend for this type of issue. Copan will continue to monitor.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002444944-2014-00003 |
| MDR Report Key | 4287489 |
| Report Source | 05,08 |
| Date Received | 2014-11-20 |
| Date of Report | 2014-10-20 |
| Date of Event | 2014-10-15 |
| Date Mfgr Received | 2014-10-20 |
| Device Manufacturer Date | 2013-06-01 |
| Date Added to Maude | 2014-12-02 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | VIA F. PEROTTI, 10 |
| Manufacturer City | BRESCIA 25125 |
| Manufacturer Country | IT |
| Manufacturer Postal | 25125 |
| Manufacturer Phone | 302687211 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COPAN TRANSYSTEM AMIES MEDIUM WITH CHARCOAL |
| Product Code | JSL |
| Date Received | 2014-11-20 |
| Model Number | 114C.USE |
| Catalog Number | 114C.USE |
| Lot Number | FCX801 |
| Device Expiration Date | 2015-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COPAN ITALIA SPA |
| Manufacturer Address | VIA F. PEROTTI, 10 BRESCIA 25125 IT 25125 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-11-20 |