MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD® URINE METER WITH BAG; KOBAYASHI DRAINAGE BAG

Model Number	153202
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.
Event or Problem Description
It was reported that there was a stain on the connector of the drainage bag.The incident was found prior to use.There was a transparent material inside of the ez-lok connector.
Additional Manufacturer Narrative
Photo sample received for evaluation.The pictures confirmed a white mark on the sample port.Although the reported issue was confirmed, the cause is unknown.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." (b)(4).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.
Event or Problem Description
It was reported that there was a stain on the connector of the drainage bag.The incident was found prior to use.There was a transparent material inside of the ez-lok connector.
Additional Manufacturer Narrative
Photo sample received for evaluation.The pictures confirmed a white mark on the sample port.Although the reported issue was confirmed, the cause is unknown.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use." (b)(4).Correction: device available for evaluation.
Event or Problem Description
It was reported that there was a stain on the connector of the drainage bag.The incident was found prior to use.There was a transparent material inside of the ez-lok connector.

• Brand Name: BARD® URINE METER WITH BAG
• Common Device Name: KOBAYASHI DRAINAGE BAG
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6531068
• Report Number: 1018233-2017-02159
• Device Sequence Number: 10972223
• Product Code: KNX
• UDI-Device Identifier: 00801741033100
• UDI-Public: (01)00801741033100
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/25/2017

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
• Operator of Device: Health Professional
• Device Model Number: 153202
• Device Catalogue Number: 153202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Initial Date Received by Manufacturer: 04/06/2017
• Supplement Date Received by Manufacturer: 07/18/2017; 08/10/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 08/02/2017; 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1