MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 DAVOL® FEMALE CATH KIT

Catalog Number	0035380
Health Effect - Clinical Code	No Information (3190)
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.The device was not returned.
Event or Problem Description
It was reported that the female catheter kit contained damaged gloves.The gloves had holes in them.
Additional Manufacturer Narrative
Upon further review, bard medical has determined that this mdr was initially reported in error as this event is not reportable.The device was not returned.
Event or Problem Description
It was reported that the female catheter kit contained damaged gloves.The gloves had holes in them.

• Brand Name: DAVOL® FEMALE CATH KIT
• Common Device Name: FEMALE CATH KIT
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• MDR Report Key: 6745614
• Report Number: 1018233-2017-03998
• Device Sequence Number: 19143102
• Product Code: FFH
• UDI-Device Identifier: 00801741045820
• UDI-Public: (01)00801741045820
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2017

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 Catalogue Number: 0035380
• Device Lot Number: NGAW1065
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/10/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1