MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 LEG BAG WITH FLIP-FLO¿ VALVE

Catalog Number	151932
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 the leg bag was missing the drain bag and extension tubing.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "package contains one leg bag and two latex leg straps*, 4-1/2¿drainage tubing, and 18¿ latex-free extension tubing." (b)(4).The device was not returned.
Event or Problem Description
It was reported that the leg bag was missing the drain bag and extension tubing.

• Brand Name: LEG BAG WITH FLIP-FLO¿ VALVE
• Common Device Name: LEG BAG
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6591814
• Report Number: 1018233-2017-02675
• Device Sequence Number: 838417
• Product Code: FAQ
• UDI-Device Identifier: 00801741050923
• UDI-Public: (01)00801741050923(17)210131(10)NGBN2329
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2017

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: Lay User/Patient
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 151932
• Device Lot Number: NGBN2329
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/01/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 05/25/2017
• Supplement Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1