MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-09-30 for MCIVOR MOUTH GAG FRAME ONLY MO141 manufactured by Carefusion.
[2238705]
We had a problem with a piece of a mcgivor mouth gag breaking off during a procedure. The incident occurred on (b)(6) 2011, surgeon dr. (b)(6). The small piece of metal that broke off was noticed and retrieved by dr. (b)(6) before entering the patients airway. No further information is available.
Patient Sequence No: 1, Text Type: D, B5
[9472082]
(b)(4). Additional information will be sent if made available.
Patient Sequence No: 1, Text Type: N, H10
[9678935]
(b)(4). Customer had a problem with a piece of a mcgivor mouth gag breaking off during a procedure. The incident occurred on (b)(6) 2011. Surgeon dr. (b)(6) was performing the procedure and noticed the small piece of metal that broke off and retrieved it before entering the patients airway. No further information is available. Device evaluation: a complaint sample was provided for evaluation. The mcgivor mouth gag frame is manufactured by one of carefusion's suppliers. Evaluation by the supplier found that the instrument had been manufactured in may of 2004. There was no material or workmanship deviation identified on this instrument. It appears that a crack formed in the instrument and eventually became deeper and broke over time. The use of an aggressive disinfection detergent may have also contributed to this. The appearance of the crack formation shows that the arm broke abruptly, however, the exact cause is unknown. A device history review (dhr) showed no recorded quality problems or rejections related to this incident. Based on the results of the investigation, no specific corrective actions have been implemented. A detailed review of the complaint history log was performed for this instrument. There were no trends identified from this review. Trending for this instrument will continue to be monitored.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423507-2011-00012 |
| MDR Report Key | 2270984 |
| Report Source | 05,06 |
| Date Received | 2011-09-30 |
| Date of Report | 2011-09-02 |
| Date of Event | 2011-09-01 |
| Date Mfgr Received | 2012-01-10 |
| Date Added to Maude | 2012-06-28 |
| 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 | JILL RITTORNO |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8474737294 |
| Manufacturer G1 | CAREFUSION 2200, INC |
| Manufacturer Street | 1500 WAUKEGAN ROAD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCIVOR MOUTH GAG FRAME ONLY |
| Generic Name | GAG, MOUTH |
| Product Code | KBN |
| Date Received | 2011-09-30 |
| Returned To Mfg | 2011-09-13 |
| Model Number | MO141 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-09-30 |