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

Model Number 0360100

Device Problem Material Twisted/Bent (2981)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that 14 catheters were bent in the packaging.

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 Description

It was reported that 14 catheters were bent in the packaging.

• Brand Name: BARD® SUCTION CATHETER TWO EYE, WHISTLE TIP WITH CONTROL VENT
• Type of Device: SUCTION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8651480
• MDR Text Key: 146480608
• Report Number: 1018233-2019-02801
• Device Sequence Number: 1
• Product Code: BSY
• UDI-Device Identifier: 00801741052453
• UDI-Public: (01)00801741052453
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1