MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX ALL-SILICONE 400-SERIES TEMPERATURE-SENSING FOLEY CATHETER; TEMP SENSING CATHETER

Catalog Number 119108

Device Problem Mushroomed (2987)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Received 1 used silicone catheter.The reported event was confirmed; however, the cause is unknown.The visual inspection noted no obvious defects and no cuff roll was observed.No others defects were observed.The functional evaluation was conducted as follows: the balloon was inflated with air and deflated, and a cuff roll was formed.Subsequently, 10 cc of a mix of water and blue methylene was introduced with a syringe, the catheter was left for 3 minutes resting on a flat surface.Then it was deflated by itself and a cuff roll was formed.The dimensional evaluation results are as follows: short side= 0.3390¿, long side=0.3585¿ (per (b)(4) specification is (b)(4)).The catheter's active length was found within specifications.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "recommended inflation capacities; 8 fr.And 10 fr.(3 cc balloon): use 3.5 cc sterile water; 12 fr.(5 cc balloon): use 5.5 cc sterile water; 14 fr.And larger (5 cc balloon): use 10 cc sterile water; do not exceed recommended capacities." 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 initially reported that the catheter was allegedly leaking urine from a small seam in the rubber.As a result of the malfunction, the device was returned for evaluation.Upon evaluation of the catheter sample (b)(6), it was noted that the catheter balloon was mushroomed.

• Brand Name: BARDEX ALL-SILICONE 400-SERIES TEMPERATURE-SENSING FOLEY CATHETER
• Type of Device: TEMP SENSING 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: 6266236
• MDR Text Key: 65708022
• Report Number: 1018233-2017-00135
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2016

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: 04/30/2021
• Device Catalogue Number: 119108
• Device Lot Number: NGAR2662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2016
• Initial Date FDA Received: 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2016
• 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