MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; LUBRISIL FOLEY CATHETER

Model Number 175816

Device Problems Break (1069); Leak/Splash (1354); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/10/2019

Event Type  Injury  

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 when the registered nurse removed the gloved hand from the patient's vagina, the foley catheter fell out of urethra onto the chux pad.The catheter was then reportedly tested with 10ml flush and no balloon inflation was observed and the flush was noted to be leaking through the end of the catheter.Upon observation of the foley catheter, it was noted that the bulb on the end of the catheter and tip of catheter appeared to be missing.The doctor reportedly performed a cystoscopy to ensure that the tip was not stuck in the patient's urethra or bladder.The tip was not observed to be inside the patient, however, it was not retrieved.The device was reportedly in use for 7 minutes when the catheter fell out of the patient.

Manufacturer Narrative

The reported event was confirmed.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley connected to a meter bag, along with a drainage tubing and a sample port connector with an intact tamper evident seal.It was noted that the catheter was missing the tip below the balloon area, but the edge of the area had a smooth surface.The missing tip did not align with the visual requirement that notes that the transition between the shaft and tip must be smooth, ridges, lines or gouges are not permitted, incomplete tips or malformed, scratched and/or with channels.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be incorrect process parameters.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: ¿proper techniques for urinary catheter insertion 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.".

Event Description

It was reported that when the registered nurse removed the gloved hand from the patient's vagina, the foley catheter fell out of urethra onto the chux pad.The catheter was then reportedly tested with 10ml flush and no balloon inflation was observed and the flush was noted to be leaking through the end of the catheter.Upon observation of the foley catheter, it was noted that the bulb on the end of the catheter and tip of catheter appeared to be missing.The doctor reportedly performed a cystoscopy to ensure that the tip was not stuck in the patient's urethra or bladder.The tip was not observed to be inside the patient, however, it was not retrieved.The device was reportedly in use for 7minutes when the catheter fell out of the patient.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRISIL FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8479026
• MDR Text Key: 140804692
• Report Number: 1018233-2019-01686
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2023
• Device Model Number: 175816
• Device Catalogue Number: 175816
• Device Lot Number: NGCW1586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention