MAUDE Adverse Event Report: C.R. BARD, INC ASPIRA DRAINAGE SYSTEM; CATHETER, PERITONEAL

Catalog Number 4992207

Device Problem Material Frayed (1262)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/22/2020

Event Type  Injury  

Event Description

On (b)(6) 2020 this (b)(6) male presented to the general surgery clinic to have his aspira drainage catheter removed.Following standard removal techniques, when the catheter was removed it was noted that the end of the catheter was short and tip was frayed.Xray confirmed a portion of the catheter remained in the patient.The patient underwent surgery to have retained portion removed.Fda safety report id# (b)(4).

• Brand Name: ASPIRA DRAINAGE SYSTEM
• Type of Device: CATHETER, PERITONEAL
• Manufacturer (Section D): C.R. BARD, INC; covington GA 30014
• MDR Report Key: 10657840
• MDR Text Key: 211059162
• Report Number: MW5097167
• Device Sequence Number: 1
• Product Code: GBW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 4992207
• Device Lot Number: REDT0476
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 39 YR