MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD LUBRI-SIL ALL-SILICONE FOLEY CATHETER

Catalog Number 175816

Device Problem No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Type  malfunction  

Event Description

It was reported that the catheter would not drain the urine from the pt's bladder.A bladder scan showed over 350 ml of urine in the bladder.The catheter was removed and a new catheter was replaced without a urine meter and there was instant urine return.Three other catheters also would not drain the bladder.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The info provided by bard represents all of the known info at this time.Despite good faith efforts to obtain additional info, the complainant/ reporter was unable or unwilling to provide any further pt, product, or procedural details to bard.

• Brand Name: LUBRI-SIL ALL-SILICONE FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4688464
• MDR Text Key: 5711317
• Report Number: 1018233-2015-00109
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2015

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 Expiration Date: 04/30/2017
• Device Catalogue Number: 175816
• Device Lot Number: NGYK3560
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/10/2015
• Was Device Evaluated by Manufacturer?: No
• 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