FDA Adverse Event Malfunction Summary report: N

MALLINKRODT

MDR report key: 1814671 · Received August 17, 2010

Report

Report Number: 2936999-2010-01082
Event Type: Malfunction
Date Received: August 17, 2010
Date of Event: July 1, 2010
Report Date: July 20, 2010
Manufacturer: COVIDIEN, FORMERLY TYCOHEALTHCARE
Product Code: JOH
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4) IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, THERE IS A DEVICE OF ESSENTIALLY IDENTICAL DESIGN DISTRIBUTED IN THE US. APPLICABLE 510K# FOR US DISTRIBUTED PART IS K873461. NO SAMPLE IS EXPECTED TO BE RETURNED FOR EVALUATION. WITHOUT THE ACTUAL COMPLAINT SAMPLES BEING RETURNED AND THE LOT NUMBER OF THE PRODUCT, A FULL INVESTIGATION CANNOT BE CARRIED OUT. A RETAINED SAMPLE FROM THE REPORTED PRODUCT CODE WILL BE REVIEWED AS PART OF THE INVESTIGATION. IF ANYTHING SIGNIFICANT IS IDENTIFIED, A SUMMARY OF THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. INFORMATION HAS BEEN ADDED TO THE DATABASE FOR TRENDING PURPOSES.

Description of Event or Problem · 1

THE COMPANY RECEIVED A REPORT OF THE FOLLOWING "REPORTER STATES USED A LASER FLEX TUBE WITH A STATED INTERNAL DIAMETER OF 6 MM TO INTUBATE A PT WITH A LARYNGEAL TUMOUR. IT WAS DIFFICULT INTUBATION DUE TO TUMOUR. TRIED TO USE A PORTEX BOUGIE SIZE 6-11 MM TO ASSIST WITH THE PLACING OF THE TUBE. THE BOUGIE WOULD NOT GO DOWN THE TUBE DUE TO THE DESIGN OF THE TUBE IN THAT THE CUFF PILOT TUBE IS SITUATED IN THE LUMEN OF THE TUBE THEREBY REDUCING THE SIZE OF THE LUMEN FROM THAT STATED ON THE PACKAGE." NO FURTHER INFORMATION WAS PROVIDED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO COLLECT FURTHER INFORMATION WITH NO RESPONSE FROM THE CUSTOMER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MALLINKRODT	4.5MM LASER FLEX CUFFED X1	JOH	COVIDIEN, FORMERLY TYCOHEALTHCARE

Patients

Seq	Age	Sex	Outcome	Treatment
1