MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SPECIALTY FOLEYS; SPECIALTY CATHETER

Device Problems Inaccurate Flow Rate (1249); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Pain (1994); Thrombus (2101); Urinary Retention (2119); Hematuria (2558)

Event Type  Injury  

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 the 3-way catheter, the nurse was not able to get urine return.The balloon was deflated and the nurse attempted to reposition the catheter.The patient allegedly experienced pain during this process.As the nurse tried to re-inflate the balloon, the infusion port ballooned up.The catheter was removed and the patient began passing large blood clots.The patient received six blood transfusions to treat the blood loss.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), rn.It was later reported from (b)(4) (international business center representative) on (b)(6) 2018; the patient was admitted for retention and hematuria.Bleeding has subsided and the reason for the foley catheter was prostatitis from prostate abcess on ct.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The product family for this specialty foley is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the specialty foley product ifus are found to be adequate based on past reviews.Correction: concomitant medical products and device evaluated by mfr.

Event Description

It was reported that during insertion of the 3-way catheter, the nurse was not able to get urine return.The balloon was deflated and the nurse attempted to reposition the catheter.The patient allegedly experienced pain during this process.As the nurse tried to re-inflate the balloon, the infusion port ballooned up.The catheter was removed and the patient began passing large blood clots.The patient received six blood transfusions to treat the blood loss.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 patient was admitted for retention and hematuria.Bleeding has subsided and the reason for the foley catheter was prostatis from prostate abcess on ct.

• Brand Name: SPECIALTY FOLEYS
• Type of Device: SPECIALTY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7735834
• MDR Text Key: 115583874
• Report Number: 1018233-2018-03138
• 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: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 08/17/2018
• Supplement Dates FDA Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention