MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CATHETER AND GLOVE SUCTION KIT WITH SOLUTION CONTAINER, TWO VINYL GLOVES, TWO EY; SUCTION CATHETER

Catalog Number	0140080
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
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 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 suction catheter was thicker than usual.
Additional Manufacturer Narrative
No sample was returned for evaluation.However the reported lot ngbq3835 is involved in the capa investigation (b)(4).Based on the investigation findings the reported problem is confirmed per previous investigations.It was created on 10/20/2017.Therefore, this reported event was confirmed as manufacturing related.The device history record was reviewed and found a possible manufacturing issue(s) that could have caused or contributed to the reported event.The instructions for use state the following: "-- (b)(4) unit not made with natural rubber latex do not use if package is damage single use do not resterilize rx only".The device was not returned.
Event or Problem Description
It was reported that the suction catheter was thicker than usual.

• Brand Name: CATHETER AND GLOVE SUCTION KIT WITH SOLUTION CONTAINER, TWO VINYL GLOVES, TWO EY
• Common Device Name: SUCTION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7407370
• Report Number: 1018233-2018-01099
• Device Sequence Number: 19241557
• Product Code: BSY
• UDI-Device Identifier: 00801741050671
• UDI-Public: (01)00801741050671
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2018

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 Expiration Date: 01/31/2021
• Device Catalogue Number: 0140080
• Device Lot Number: NGBQ3835
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 04/09/2018
• Supplement Report FDA Received Date: 05/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1