MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URINE COLLECTION; UNKNOWN BAG

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250); Patient-Device Incompatibility (2682); Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)

Patient Problems Pain (1994); Urinary Retention (2119); Discomfort (2330); Impaired Healing (2378); Patient Problem/Medical Problem (2688)

Event Date 02/18/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that on (b)(6), the patient had a robotic assisted laparoscopic prostatectomy.They stayed overnight in the hospital and were released the next day.When the patient was leaving the hospital, the nurse took off the strain relief pad which prevents strain on the penis and added 4 inches of tubing to the bag.The tubing hung down and dragged the penis catheter with it.The patient stated it was not very comfortable.There was no patient injury reported.In addition, the urine collection bag did not allow drainage relief to the bladder and the patient experienced pain and pressure.When the patient got home, they were able to release about 64 oz.Of urine.The patient stated they had the catheter in for two weeks and then the doctor said they would deflate the internal bulb and pull out the catheter.The customer stated they had leakage outside of the catheter which requires depends.In addition, the patient stated the anti reflux valve inside of the day bag stuck together and blocked flow into the bag.The patient stated that the tubing was unnecessary as the bag should be connected directly to the foley catheter.The patient stated no lasting harm was done.The doctor replaced the bag with one manufactured by mckesson.Per follow up received from the customer on 28mar2020, the patient stated when he went to the doctor the next morning the doctor removed the bard bag and hose and discarded both.His nurse added a bard snap lock strain relief and a mckesson bag.The mckesson bag came with no extra plastic hose and was connected directly to the foley catheter.The experience caused damage to the stitches between the bladder and the urethra (the prostate was removed during the surgery) causing leakage at the suture.This caused a two week delay (four weeks total) to the catheter removal and provided extra time for the urethra to heal.

Manufacturer Narrative

The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿not biocompatible¿ with a potential root cause of ¿materials of construction are not biocompatible, inadequate biological evaluation¿.The lot number is unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bard is unable to determine the associated labeling to review.Corrections: b1, b2.

Event Description

It was reported that on (b)(6), the patient had a robotic assisted laparoscopic prostatectomy.They stayed overnight in the hospital and were released the next day.When the patient was leaving the hospital, the nurse took off the strain relief pad which prevents strain on the penis and added 4 inches of tubing to the bag.The tubing hung down and dragged the penis catheter with it.The patient stated it was not very comfortable.There was no patient injury reported.In addition, the urine collection bag did not allow drainage relief to the bladder and the patient experienced pain and pressure.When the patient got home, they were able to release about 64 oz.Of urine.The patient stated they had the catheter in for two weeks and then the doctor said they would deflate the internal bulb and pull out the catheter.The customer stated they had leakage outside of the catheter which requires depends.In addition, the patient stated the anti reflux valve inside of the day bag stuck together and blocked flow into the bag.The patient stated that the tubing was unnecessary as the bag should be connected directly to the foley catheter.The patient stated no lasting harm was done.The doctor replaced the bag with one manufactured by (b)(4).Per follow up received from the customer on (b)(6) 2020, the patient stated when he went to the doctor the next morning the doctor removed the bard bag and hose and discarded both.His nurse added a bard snap lock strain relief and a (b)(4) bag.The (b)(4) bag came with no extra plastic hose and was connected directly to the foley (b)(4) experience caused damage to the stitches between the bladder and the urethra (the prostate was removed during the surgery) causing leakage at the suture.This caused a two week delay (four weeks total) to the catheter removal and provided extra time for the urethra to heal.

• Brand Name: URINE COLLECTION
• Type of Device: UNKNOWN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9973194
• MDR Text Key: 188329951
• Report Number: 1018233-2020-02655
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/28/2020

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/28/2020
• Initial Date FDA Received: 04/17/2020
• Supplement Dates Manufacturer Received: 04/23/2020
• Supplement Dates FDA Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other