MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; OPEN HEART PACK

Catalog Number CDS984948C

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2016

Event Type  Injury  

Manufacturer Narrative

The account reported that a tag from either a white or a blue towel was found in the operative site during a surgical procedure.The tag was manually removed by the surgeon.The site was not irrigated.There was no serious injury or the need for any additional medical intervention.The procedure continued without further incident.A new sample was returned for evaluation.The towel which was reported to not have the tag securely fastened to the towel was not returned with the sample.In the absence of an actual sample, a root cause has not been determined.Due to the reported incident, this medwatch is being filed.

Event Description

The account reported that a tag from either a white or a blue or towel was found in the operative site and was removed.

• Type of Device: OPEN HEART PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• Manufacturer Contact: diane christensen ; one medline place; mundelein, IL 60060 ; 8476434747
• MDR Report Key: 5510761
• MDR Text Key: 40687961
• Report Number: 1423395-2016-00026
• Device Sequence Number: 1
• Product Code: LRO
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: CDS984948C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 02/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Weight: 81