MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 LUBRI-SIL IC TRAY 18FR; URINE DRAINAGE BAG

Catalog Number 6610J18C

Device Problem Occlusion Within Device (1423)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2017

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 an occlusion was found inside of the outlet tube of the urine drainage bag.The user allegedly could not dispose of the accumulated urine.

Manufacturer Narrative

Received 1 used drainage bag only.The reported event was unconfirmed, as the product could not be reproduced.The returned sample was visually inspected and no obvious defects were observed.Per functional evaluation, the received sample was filled with water (1000 ml approximately) subsequently the water was drained out the bag through the outlet tube and the water flow out the retuned bag with no issues.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: " contraindications -method not for use -do not desterilize -this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine, consider using alternative disinfectants.-be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetables oils such as olive oil, mineral oils such as white petroleum and animal oils).[they may damage the device and may burst the balloon.] -do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon]." (b)(4).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 an occlusion was found inside of the outlet tube of the urine drainage bag.The user allegedly could not dispose of the accumulated urine.

• Brand Name: LUBRI-SIL IC TRAY 18FR
• Type of Device: URINE DRAINAGE BAG
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; lot 57c; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): BARD SDN. BHD. -8040607; kulim industrial estate; lot 57c; kulim, kedah 09000 ; MY 09000
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6347725
• MDR Text Key: 68212136
• Report Number: 1018233-2017-00575
• 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: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/27/2017

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 Catalogue Number: 6610J18C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2017
• Initial Date FDA Received: 02/21/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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