MAUDE Adverse Event Report: TELEFLEX MEDICAL PILLING; BOUGIE, ESOPHAGEAL, ENT

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Information (3190)

Event Date 01/22/2019

Event Type  Injury  

Event Description

Mfr identified issues with the outer packaging of the products being improperly labeled.The product itself is properly labeled.Because of this, manufacturer recommends removing product containers out of service.However, our facility always immediately removes items from the container and verifies size on the device itself.And since the device itself is not an issue, and packaging is immediately discarded, no further action is needed at this time.

• Brand Name: PILLING
• Type of Device: BOUGIE, ESOPHAGEAL, ENT
• Manufacturer (Section D): TELEFLEX MEDICAL
• MDR Report Key: 8277961
• MDR Text Key: 134438275
• Report Number: MW5083391
• Device Sequence Number: 1
• Product Code: KCD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention