MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 SILICONE FOLEY CATHETER; SILICONE CATHETER

Device Problems Difficult to Remove (1528); Structural Problem (2506)

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

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 the device had ridges on the end; the complainant stated that the device was allegedly difficult to remove.

Manufacturer Narrative

Received 1 used silicone catheter with the drainage bag only.The catheter bifurcation channel appeared to have been cut off.The channel was not returned with the sample.Visual inspection noted no obvious defects.Unable to verify the reported event without testing the sample.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "the following instructions are indicated: recommended inflation capacities 3cc balloon: use 5ml sterile water, 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water, do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make 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." (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 the device had ridges on the end.The complainant stated that the device was allegedly difficult to remove.

• Brand Name: SILICONE FOLEY CATHETER
• Type of Device: SILICONE CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6355195
• MDR Text Key: 68501698
• Report Number: 1018233-2017-00659
• 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,other,use
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/20/2017

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2017
• Initial Date FDA Received: 02/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/20/2017
• 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