MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SPECIALTY FOLEYS; UNKNOWN FOLEY CATHER LATEX

Device Problems Difficult to Insert (1316); Inadequacy of Device Shape and/or Size (1583); Failure to Advance (2524)

Patient Problems Thrombus (2101); Hematuria (2558)

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 during insertion of a 3-way catheter, the nurse was unable to advance the catheter.There were blood clots and pinkish urine returned in the catheter drainage tubing.The nurse felt the catheter was too large for the patient and the 3-way catheter was aborted.A regular indwelling catheter was placed.No additional medical interventions were reported.Clinical statement: the intended use for a 3-way catheter is used for drainage after bladder or upper urinary tract surgeries to add continuous irrigation capabilities.Continuous irrigation catheters help to remove tissue chips, blood clots and other debris form the bladder after surgery.(b)(6).It was later reported from (b)(6) (international business center representative) on (b)(6) 2018; the irrigation catheters were used for retention due to cervical cancer and to help conserve energy as patient was frail.The indwelling catheter was not the same french size as the 3 way, a size 14 was used with no problems with insertion.The nurse stated that the catheter was too large because the wrong size was used.

Event Description

It was reported that during insertion of a 3-way catheter, the nurse was unable to advance the catheter.There were blood clots and pinkish urine returned in the catheter drainage tubing.The nurse felt the catheter was too large for the patient and the 3-way catheter was aborted.A regular indwelling catheter was placed.No additional medical interventions were reported.Clinical statement: the intended use for a 3-way catheter is used for drainage after bladder or upper urinary tract surgeries to add continuous irrigation capabilities.Continuous irrigation catheters help to remove tissue chips, blood clots and other debris form the bladder after surgery.Tschlager, rn it was later reported from melissa sanz (international business center representative) on (b)(6) 2018; the irrigation catheters were used for retention due to cervical cancer and to help conserve energy as patient was frail.The indwelling catheter was not the same french size as the 3 way, a size 14 was used with no problems with insertion.The nurse stating that the catheter was too large because the wrong size was used.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product catalog number is unknown, catheter product ifus are found to be adequate based on past reviews.

• Brand Name: SPECIALTY FOLEYS
• Type of Device: UNKNOWN FOLEY CATHER LATEX
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7735839
• MDR Text Key: 115903739
• Report Number: 1018233-2018-03140
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/20/2018
• Supplement Dates FDA Received: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 0