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

Catalog Number A303316A

Device Problem Improper Flow or Infusion (2954)

Patient Problems Urinary Retention (2119); Injury (2348)

Event Type  Injury  

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 bag would not drain properly causing the patient's bladder to be full.It was alleged that due to the bladder being full during a c-section the bladder was nicked.No medical/surgical intervention was taken to repair the nicked bladder, however, the catheter remained indwelling in the patient an additional 10 days for the bladder to heal.No further patient complications were reported.

Manufacturer Narrative

Received 1 used urinary drainage bag with the foley catheter still attached.Visual inspection noted no obvious defects.The received sample was functionally tested by passing water through a 14fr.Catheter (part of the sample received)/ pvc inlet tube towards the interior of the drip chamber / drainage bag.No drainage problems were noted; the flow was continuous during the test on the sample received.The drainage test for catheters/drainage bags indicates that 250cc must be drained in 64 seconds maximum.The results were the following: time to drain 250cc: 75 sec.The sample received reached the intended drainage indicated in less than 87 seconds.The reported event is unconfirmed as the sample returned was found to be within specifications.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use state the following: "maintain unobstructed urine flow and keep the catheter and collection tube free from kinking.Keep the collection bag below the level of the bladder or hips at all times.Empty the collection bag regularly (e.G.Prior to transport) using a separate, clean collection container for each patient." (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.

• Brand Name: URNMTRFOLYTRYCLCTN
• Type of Device: FOLEY TRAY
• 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5157658
• MDR Text Key: 28556001
• Report Number: 1018233-2015-00390
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: A303316A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2015
• 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
• Patient Outcome(s): Required Intervention