MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LATEX RUBBER CATHETER AND GLOVE SUCTION KIT WITH SOLUTION CONTAINER, CSR WRAP, T; TRACHEAL SUCTION CATHETER

Model Number	0140020
Medical Device Problem Code	Incorrect Measurement (1383)
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.
Event or Problem Description
It was reported that the diameter of the catheters were larger than usual, making the catheters unusable.
Additional Manufacturer Narrative
The reported event is confirmed as manufacturing related.Visual evaluation of the returned sample noted an unopened (sealed, original packaging) unused catheter kit.The kit was opened and the catheter was inspected.No visible defects were noted.The diameter of the returned catheter was measured (0.2175") and found to be out of specification.The french size of the catheter was also measured (17 fr) and was also found to be out of specification (15 fr).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: "do not use if package is damaged.Single use do not resterilize rx only".
Event or Problem Description
It was reported that the diameter of the catheters were larger than usual, making the catheters unusable.

• Brand Name: LATEX RUBBER CATHETER AND GLOVE SUCTION KIT WITH SOLUTION CONTAINER, CSR WRAP, T
• Common Device Name: TRACHEAL SUCTION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7541325
• Report Number: 1018233-2018-01863
• Device Sequence Number: 1529147
• Product Code: BSY
• UDI-Device Identifier: 00801741052484
• UDI-Public: (01)00801741052484
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2018

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: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Model Number: 0140020
• Device Catalogue Number: 0140020
• Device Lot Number: NGBX4280
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2018
• Initial Date Received by Manufacturer: 05/02/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 05/24/2018
• Supplement Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1