MAUDE Adverse Event Report: C. R. BARD, INC. BARD; APPARATUS,SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Catalog Number 072230

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/29/2020

Event Type  malfunction  

Event Description

Hair discovered inside the first/outer packaging/peel package.Package not opened and not used; saved for quality.

• Brand Name: BARD
• Type of Device: APPARATUS,SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C. R. BARD, INC.; 1211 mary magnan blvd; madison GA 30650
• MDR Report Key: 10100753
• MDR Text Key: 192665067
• Report Number: 10100753
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 072230
• Device Lot Number: NGDZ3035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/01/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1