MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER INSERTION TRAY; FOLEY TRAY

Model Number 802110

Device Problem Nonstandard Device (1420)

Patient Problems Itching Sensation (1943); Pain (1994); Skin Discoloration (2074); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 04/27/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the foley catheter tray kit used for patient with multiple sclerosis.It was also stated that the nurse attendant noticed the disinfectant on the tips of the provided cotton swabs were clear instead of orange.Nurse attendant used it anyway, and a few days later, the patient experienced swelling and pain.No medical intervention was reported.

Event Description

It was reported that the foley catheter tray kit used for patient with multiple sclerosis.Stated that the nurse attendant noticed the disinfectant on the tips of the provided cotton swabs were clear instead of orange.Nurse attendant used it anyway, and a few days later, the patient experienced swelling and pain.No medical intervention was reported.As per the follow-up via email on 24may2022, it was reported that the first of the three devices was used by a registered nurse approximately four weeks ago and noticed that the cotton tips of the swab sticks were not of the same color as previous devices.The tips of the recent ones used were coated with a clear liquid, whereas ones used in the past were of a yellowish-red iodine color.The nurse did proceed to use them in the same manner as they had used the swabs in the past, even though the tips were of a different color.Approximately 36 hours later the patient noticed swelling on the left side of the outer vagina and patient was examined by doctor of medicine, who then prescribed fluconazole oral tablets.The next day the patient broke out in hives all over her body and hives were painful and caused severe itching.The doctor of medicine told to discontinue the fluconazole, and ordered nystatin topical powder to apply to the vaginal area only.In the meantime cortisone ointment was applied to the areas of the hives.Use of all three of the medications had since been discontinued, although there were still small areas of redness from the hives.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.

Manufacturer Narrative

The reported event was unconfirmed because the device meets specifications.The swabs reported by the customer were used for treatment, however, the returned swabs were unused.No root cause could be found because the reported event was unconfirmed.A device history record review was not required as the investigation was unconfirmed.The investigation is concluded, and no additional action is required at this time.As the reported event is unconfirmed a labeling review is not required.H11: section a through f - the information provided by bd represents all 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.H3 other text: the actual/suspected device was inspected.

Event Description

It was reported that the foley catheter tray kit used for patient with multiple sclerosis.Stated that the nurse attendant noticed the disinfectant on the tips of the provided cotton swabs were clear instead of orange.Nurse attendant used it anyway, and a few days later, the patient experienced swelling and pain.No medical intervention was reported.As per the follow-up via email on 24 may 2022, it was reported that the first of the three devices was used by a registered nurse approximately four weeks ago and noticed that the cotton tips of the swab sticks were not of the same color as previous devices.The tips of the recent ones used were coated with a clear liquid, whereas ones used in the past were of a yellowish-red iodine color.The nurse did proceed to use them in the same manner as they had used the swabs in the past, even though the tips were of a different color.Approximately 36 hours later the patient noticed swelling on the left side of the outer vagina and patient was examined by doctor of medicine, who then prescribed fluconazole oral tablets.The next day the patient broke out in hives all over her body and hives were painful and caused severe itching.The doctor of medicine told to discontinue the fluconazole, and ordered nystatin topical powder to apply to the vaginal area only.In the meantime cortisone ointment was applied to the areas of the hives.Use of all three of the medications had since been discontinued, although there were still small areas of redness from the hives.

• Brand Name: BARDIA® FOLEY CATHETER INSERTION TRAY
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14469399
• MDR Text Key: 292367741
• Report Number: 1018233-2022-03998
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741018268
• UDI-Public: (01)00801741018268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 802110
• Device Catalogue Number: 802110
• Device Lot Number: NGFZ2851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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 Outcome(s): Required Intervention; Other
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 95 KG