MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DEL LA SALUD BARDEX LBRI-SIL I.C. ALL SILICONE FOLEY CATHETER

Catalog Number 1758SI12

Device Problems Material Deformation (2976); Mushroomed (2987)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Type  malfunction  

Event Description

It was reported that the device developed a ridge when it was deflated.The patient reports that the nurse deflated his catheter by aspirating the catheter which caused a ridge to develop around the balloon.Upon removal, the patient experienced pain and self limiting bleeding.

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.

Manufacturer Narrative

Received 1 used silicone foley catheter.Per visual evaluation, heavy calcification along the catheter and cuff roll was found.Functional testing was performed by inflating the balloon w/air using an in house syringe and deflated a cuff roll was formed.The catheters active length was found within specification.The reported event was confirmed with the case unknown.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following "note: aggressive traction, particularly in presence of suturing is not recommended for 100% silicone foley catheters.To deflate catheter balloon: gently insert a syringe in the syringe "stick" in the valve if you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its' own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities.5cc balloon: use 10cc sterile water 30cc.Balloon: use 35cc sterile water.Do not exceed recommended capacities.(b)(4).

• Brand Name: BARDEX LBRI-SIL I.C. ALL SILICONE FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DEL LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km. 7 carretera int'l; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4798451
• MDR Text Key: 5925090
• Report Number: 1018233-2015-00166
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,consumer,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2015

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: Lay User/Patient
• Device Expiration Date: 07/21/2019
• Device Catalogue Number: 1758SI12
• Device Lot Number: NGYF2923
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/02/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 05/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2014
• 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