MAUDE Adverse Event Report: CARDINAL HEALTH BLUE BOUFFANT, 24"; CAP, SURGICAL

Catalog Number B24HD

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Itching Sensation (1943); Skin Discoloration (2074)

Event Date 04/14/2014

Event Type  Injury  

Manufacturer Narrative

The device history record was reviewed, and no exception was detected that could have resulted in the reported defect.Historical trending was done, and this is the first reported incident in the past 12 months.The actual bouffant worn was not available.However, samples from the same box were evaluated against raw material and product specification.The bouffants met both raw material and product specification requirements.A review of the samples did not show any abnormality.The material used for the bouffant is polypropylene with calcium carbonate which passed biocompatibility tests prescribed by the regulatory agency for the intended use, and there was no change in the material composition, including elastic and thread.The root cause could not be determined.The complaint information was fedback to the related personnel for awareness.There is no corrective action at this time, but we will continue to monitor complaints for any trends of this nature.

Event Description

The patient was having a permanent pacemaker implanted.All patients must wear a head covering.At the conclusion of the implant, the patient had redness and itching on her head.She was given iv benadryl, no other treatment was required.

• Brand Name: BLUE BOUFFANT, 24"
• Type of Device: CAP, SURGICAL
• Manufacturer (Section D): CARDINAL HEALTH; singapore ; SN
• Manufacturer (Section G): CARDINAL HEALTH SINGAPORE 225 PTE LTD; 80 anson rd; singapore 0799 07; SN 079907
• Manufacturer Contact: michele donatich ; 1500 waukegan road; waukegan, IL 60085 ; 8478876412
• MDR Report Key: 3799720
• MDR Text Key: 19388495
• Report Number: 1423537-2014-00015
• Device Sequence Number: 1
• Product Code: FYF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: B24HD
• Device Lot Number: 13LCB311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2013
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 90 YR
• Patient Weight: 54