MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 DAVOL PLASTIC CATH 'N SLEEVE WITH SOLUTION CONTAINER; TRACHEAL SUCTION CATHETER KIT

Catalog Number	0089100
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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 device was not returned.
Event or Problem Description
It was reported that the catheter from the tracheal suction catheter kit failed visual analysis.The product was detained at the border by fda customs, where it was randomly selected to be sampled and sent to an fda selected laboratory for inspection.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿this is a single use device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristic of the device, which may lead to device failure and or lead to injury illness death of the patient.".
Event or Problem Description
It was reported that the catheter from the tracheal suction catheter kit failed visual analysis.The product was detained at the border by fda customs, where it was randomly selected to be sampled and sent to an fda selected laboratory for inspection.

• Brand Name: DAVOL PLASTIC CATH 'N SLEEVE WITH SOLUTION CONTAINER
• Common Device Name: TRACHEAL SUCTION CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8134787
• Report Number: 1018233-2018-05856
• Device Sequence Number: 13930870
• Product Code: BSY
• UDI-Device Identifier: 00801741050206
• UDI-Public: (01)00801741050206
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2019

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: Other
• Device Catalogue Number: 0089100
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/16/2018
• Supplement Date Received by Manufacturer: 01/04/2019
• Initial Report FDA Received Date: 12/05/2018
• Supplement Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1