MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® SUCTION CATHETER TWO EYE, WHISTLE TIP WITH CONTROL VENT

Model Number	0360100
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.
Event or Problem Description
It was reported that 14 catheters were bent in the packaging.
Additional Manufacturer Narrative
The reported event was confirmed.A root cause could not be determined.The inspector received 20 unused suction catheters.It was noted that the catheter tubing on all of the samples were curved and bent.A potential root cause for this failure could be "incorrect operation." the device history record was reviewed and found nothing that could have caused or contributed to the reported event.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 lea to injury, illness or death of the patient." h11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that 14 catheters were bent in the packaging.

• Brand Name: BARD® SUCTION CATHETER TWO EYE, WHISTLE TIP WITH CONTROL VENT
• Common Device Name: SUCTION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8651480
• Report Number: 1018233-2019-02801
• Device Sequence Number: 11404673
• Product Code: BSY
• UDI-Device Identifier: 00801741052453
• UDI-Public: (01)00801741052453
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2019

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: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: 0360100
• Device Catalogue Number: 0360100
• Device Lot Number: NGCS2109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 07/04/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 07/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1