MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES

Catalog Number 165812

Device Problems Hole In Material (1293); Device Operates Differently Than Expected (2913)

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 a pinhole was allegedly noted in the catheter; however, the location of the pinhole was unknown.The catheter was inserted; however, the device was unable to drain.As a result, the device was replaced.

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 a pinhole was allegedly noted in the catheter; however, the location of the pinhole was unknown.The catheter was inserted; however, the device was unable to drain.As a result, the device was replaced.Subsequently; the device was returned for evaluation, at which time it was noted that the balloon had ruptured.It was later reported by the complainant, that there was no certainty in whether pieces remained in the patient or not.

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 a pinhole was allegedly noted in the catheter; however, the location of the pinhole was unknown.The catheter was inserted; however, the device was unable to drain.As a result, the device was replaced.Subsequently; the device was returned for evaluation, at which time it was noted that the balloon had ruptured.It was later reported by the complainant, that there was no certainty in whether pieces remained in the patient or not.

Manufacturer Narrative

Received 1 used silicone catheter with the original unit labeling.Per the visual evaluation, it was noted that the balloon had ruptured / burst.However, no pieces were missing.Per the dimensional evaluation, the active length was measured and the results were as follows: short side= 0.5325¿, long side=0.5380¿ (per specification, the active length is 0.5¿ to 0.8¿).Therefore, the catheter active length was found within specification.The reported issue was confirmed with an unknown cause.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 3 cc balloon: use 5 ml sterile water, 5 cc balloon: use 10 ml sterile water, 30 cc balloon: use 35 ml sterile water, do not exceed recommended capacities.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.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 a pinhole was allegedly noted in the catheter; however, the location of the pinhole was unknown.The catheter was inserted; however, the device was unable to drain.As a result, the device was replaced.Subsequently; the device was returned for evaluation, at which time it was noted that the balloon had ruptured.It was later reported by the complainant, that there was no certainty in whether pieces remained in the patient or not.

• Brand Name: BARDEX 2-WAY 5CC ALL-SILICONE FOLEY CATHETER, TWO OPPOSED EYES
• Type of Device: SILICONE FOLEY 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: 6222111
• MDR Text Key: 64182172
• Report Number: 1018233-2017-00033
• 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: other,user facility
• Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/16/2017

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
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: 165812
• Device Lot Number: NGAP1336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/04/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/24/2017; 02/14/2017; 03/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2016
• 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