MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER

Model Number 175816

Device Problem Difficult to Insert (1316)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 07/20/2022

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 patient had experienced urinary retention, primarily attempted to place silicone foley catheter, and had immediate blood returned and unable to advance the catheter.Medical doctor and urology notified, and orders received to place a coude.Stated that the coude catheter placed with small amount of blood and immediate clear yellow urine.On (b)(6) 2022, stated that the foley kit with temperature cable was faulty, black temperature cable was not reading accurately.Removed and new kit opened, the black temperature cable was replaced and now functional.On (b)(6)2021, stated that there have been six foley catheters which required aggressive flushing and irrigation.After flushing, substantial amounts of urine output occurred.The attending and staff feel this could be related to a batch of defective foleys.On (b)(6) 2021, customer had trouble with foley catheters draining like they should.They had to flush the foleys, after flushing, they would get 1000 - 1500 ml urine out.The product also felt different texture wise like the foley tubing was not as rigid, now have multiple kinks in them and it did not automatically correct the kinks.This was the 11th foley that our team has had to flush in a 1-week period and then would get back a large volume of urine.Customer would like to avoid a bladder rupture at all costs.No medical intervention was reported.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "tortuous anatomy (e.G.Enlarged prostate)".It was unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number and the lot number for this device are unknown.Therefore, bd was unable to determine the associated labeling to review.Corrections: d,h 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 device was not returned.

Event Description

It was reported that the patient had experienced urinary retention, primarily attempted to place silicone foley catheter, and had immediate blood returned and unable to advance the catheter.Medical doctor and urology notified, and orders received to place a coude.Stated that the coude catheter placed with small amount of blood and immediate clear yellow urine.On (b)(6) 2022, stated that the foley kit with temperature cable was faulty, black temperature cable was not reading accurately.Removed and new kit opened, the black temperature cable was replaced and now functional.On (b)(6)2021, stated that there have been six foley catheters which required aggressive flushing and irrigation.After flushing, substantial amounts of urine output occurred.The attending and staff feel this could be related to a batch of defective foleys.On (b)(6) 2021, customer had trouble with foley catheters draining like they should.They had to flush the foleys, after flushing, they would get 1000 - 1500 ml urine out.The product also felt different texture wise like the foley tubing was not as rigid, now have multiple kinks in them and it did not automatically correct the kinks.This was the 11th foley that our team has had to flush in a 1-week period and then would get back a large volume of urine.Customer would like to avoid a bladder rupture at all costs.No medical intervention was reported.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: ALL SILICONE CATHETER
• 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: 15157202
• MDR Text Key: 304888124
• Report Number: 1018233-2022-06001
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741034169
• UDI-Public: (01)00801741034169
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

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: Health Professional
• Device Model Number: 175816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 10/21/2022
• Supplement Dates FDA Received: 10/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other