MAUDE Adverse Event Report: COVIDIEN SHILEY; PACK.ASS.CUF LONG PED 6.5 BX1

Model Number 6.5PLC

Device Problems Material Too Rigid or Stiff (1544); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Patient information (id, age, sex, weight) as well as additional information associated with the complaint have been requested and is either unknown, will not be made available to medtronic, or will be provided and updated in a supplemental report.

Event Description

Covidien received a report the cuff felt stiff opposed to the normal usage.There was no patient harm with this event.Covidien has requested additional information regarding the circumstances of the patient event.

Manufacturer Narrative

One sample was received for analysis and the reported issue was confirmed.A inflation/deflation test was performed and t was observed the cuff deflated immediately.A visual inspection was performed and it was observed the inflation line is broken at flange connection.

Event Description

Medtronic received a report the cuff felt stiff opposed to the normal usage.There was no patient harm with this event.

• Brand Name: SHILEY
• Type of Device: PACK.ASS.CUF LONG PED 6.5 BX1
• Manufacturer (Section D): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer (Section G): COVIDIEN; avenida henequen; 1181 parque industrial salvarcar; cd. juarez, chihuahua ; MX
• Manufacturer Contact: ray maroofian ; 2101 faraday ave; carlsbad, CA 92008 ; 7606035334
• MDR Report Key: 6351711
• MDR Text Key: 68280748
• Report Number: 2936999-2017-00124
• Device Sequence Number: 1
• Product Code: JOH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K955680
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,user facilit
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6.5PLC
• Device Catalogue Number: 6.5PLC
• Device Lot Number: 16B0914JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1