MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD FOLEY TRAY WITH BARD HYDROPHILIC-COATED FOLEY CATHETER

Model Number 800061

Device Problem Inadequate Instructions for Healthcare Professional (1319)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

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 the catheter in the bard foley tray contain natural rubber latex as per the box, but the description in the box was mentioned as latex free.The customer service responded that the product was processed differently.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.Visual evaluation of the photo sample noted one foley tray label on a cardboard box.Visual inspection of the sample noted that the label actually did have a latex warning.The label states " caution: this product contains natural rubber latex which may cause allergic reactions".No root cause could be found because the reported event was unconfirmed.The device history record review was not required as the reported event was unconfirmed.The instructions for use were found adequate and state the following: ¿ perform hand hygiene immediately before and after insertion ¿ insert urinary catheters using aseptic technique and sterile equipment ¿ use the smallest foley catheter possible, consistent with good drainage ¿ document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in patient record proper techniques for urinary catheter maintenance ¿ secure the foley catheter, use the statlock® foley stabilization device if provided ¿ maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions ¿ maintain unobstructed urine flow and keep the catheter and collection tube free from kinking ¿ keep the collection bag below the level of the bladder or hips at all times ¿ empty the collection bag regularly (e.G., prior to transport) using a separate, clean collection container for each patient ¿ routine hygiene (e.G., cleansing of the meatal surface during daily bathing or showering) is appropriate ¿ leave foley catheter in place only as long as needed ez-lok® sampling port fig.3 fig.2 fig.1a fig.1b sterilized using ethylene oxide." h11: section a through f - 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.H3 other text : the actual/suspected device was inspected.

Event Description

It was reported that the catheter in the bard foley tray contain natural rubber latex as per the box, but the description in the box was mentioned as latex free.The customer service responded that the product was processed differently.

• Brand Name: BARD FOLEY TRAY WITH BARD HYDROPHILIC-COATED FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11367291
• MDR Text Key: 233192419
• Report Number: 1018233-2021-00731
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741024153
• UDI-Public: (01)00801741024153
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: 800061
• Device Catalogue Number: 800061
• Device Lot Number: NGDZ2777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other