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

Catalog Number UNKNOWN

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Irritation (1941); 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.The device was not returned.

Event Description

It was reported that during the insertion of a 3-way catheter, frank blood was noted to return in the catheter's drainage tubing.The patient required continuous bladder irrigation for 3 weeks due to the bleeding and blood clots.The patient also has a prior history of enlarged prostate, prostate abscess, and an elevated inr.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 per additional information received on 07/27/2018 from (b)(4), the patient was admitted for urinary retention.The catheter was removed, and the bleeding eventually subsided.The clinician stated that the possible reason for the urine retention may have been caused by radiation cystitis and the hematuria may have been related to the irritation in the bladder from the radiation cystitis.

Manufacturer Narrative

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

Event Description

It was reported that during the insertion of a 3-way catheter, frank blood was noted to return in the catheter's drainage tubing.The patient required continuous bladder irrigation for 3 weeks due to the bleeding and blood clots.The patient also has a prior history of enlarged prostate, prostate abscess, and an elevated inr.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 per additional information received on (b)(6)2018 from ibc, the patient was admitted for urinary retention.The catheter was removed, and the bleeding eventually subsided.The clinician stated that the possible reason for the urine retention may have been caused by radiation cystitis and the hematuria may have been related to the irritation in the bladder from the radiation cystitis.

• Brand Name: SPECIALTY FOLEYS
• Type of Device: SPECIALITY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7786605
• MDR Text Key: 117256433
• Report Number: 1018233-2018-03588
• 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: 09/20/2018

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 09/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other