MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT; TOUCHLESS PLUS RED RUBBER COUDE CATHETER

Model Number 4A7044

Device Problem Material Integrity Problem (2978)

Patient Problems Irritation (1941); Blood Loss (2597)

Event Type  malfunction  

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 Description

It was reported that the lubricant on the catheter seemed to be powdery and gritty.The patient reported that he attempted to use the catheter and due to the lack of lubrication, he allegedly experienced self-limited bleeding and irritation of the urethra upon insertion and believed it "cut his sphincter." the patient visited the emergency room as a precautionary measure since he is currently prescribed a blood thinner, xarelto.The patient reported that the staff in the emergency room was able to successfully place a new catheter and no additional medical treatment was provided.

Manufacturer Narrative

No physical sample was returned for evaluation.A photo was provided to evaluate.The reported issue was inconclusive due to the poor sample condition.Per the photos received, the reported issue could not be confirmed.The physical sample is needed to confirm the defect.A current process was reviewed and all was found within specification.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: "- sterilized using ethylene oxide.Do not resterilize.Do not use if package is damaged." (b)(4).

Event Description

It was reported that the lubricant on the catheter seemed to be powdery and gritty.The patient reported that he attempted to use the catheter and due to the lack of lubrication, he allegedly experienced self-limited bleeding and irritation of the urethra upon insertion and believed it "cut his sphincter." the patient visited the emergency room as a precautionary measure since he is currently prescribed a blood thinner, xarelto.The patient reported that the staff in the emergency room was able to successfully place a new catheter and no additional medical treatment was provided.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED RUBBER URETHRAL CATHETER KIT
• Type of Device: TOUCHLESS PLUS RED RUBBER COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6955625
• MDR Text Key: 89687326
• Report Number: 1018233-2017-05320
• Device Sequence Number: 1
• Product Code: FCM
• UDI-Device Identifier: 00801741030536
• UDI-Public: (01)00801741030536
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/08/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 4A7044
• Device Catalogue Number: 4A7044
• Device Lot Number: NGBT1748
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/17/2017
• Supplement Dates Manufacturer Received: 12/05/2017
• Supplement Dates FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 48 YR