MAUDE Adverse Event Report: C. R. BARD, INC. BARD DRAIN; CATHETER, IRRIGATION

Model Number 0070370

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/05/2022

Event Type  Injury  

Event Description

The patient underwent a kidney transplant on (b)(6) 2022 during which a 10fr flat drain was placed.On (b)(6) 2022, the physician attempted to remove the drain and it was evident from the appearance that the drain had fractures and pieces of the drain were retained.Ultimately, on (b)(6) 2022 the patient was taken to the operating room for removal of the retained drain fragments.Fda safety report id# (b)(4).

• Brand Name: BARD DRAIN
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): C. R. BARD, INC.; covington GA 30014
• MDR Report Key: 15380683
• MDR Text Key: 299694000
• Report Number: MW5111930
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• 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: 09/06/2022

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: Health Professional
• Device Model Number: 0070370
• Device Catalogue Number: 0070370
• Device Lot Number: NGFZ4211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 74 KG
• Patient Ethnicity: Hispanic