MAUDE Adverse Event Report: PRODUCTOS PARA EL C UIDADO DE LA SALUD BARD URINARY 2 LITER DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

Catalog Number 154006

Device Problem Insufficient Information (3190)

Patient Problems Unspecified Infection (1930); Alteration In Body Temperature (2682)

Event Type  Injury  

Event Description

It ws reported by the patient's attorney that as a result of using the urinary drainage bag the patient experienced a urinary tract infection.The patient has been treated with unspecified antibiotics.

Manufacturer Narrative

The sample was not returned; therefore the investigation is inconclusive.The lot number is unknown; therefore, the device history record could not be reviewed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.(b)(4).

• Brand Name: BARD URINARY 2 LITER DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Manufacturer (Section D): PRODUCTOS PARA EL C UIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4744979
• MDR Text Key: 5824937
• Report Number: 1018233-2015-00130
• Device Sequence Number: 1
• Product Code: KNX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Attorney
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 154006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/06/2015
• 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: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention