MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE FOLEY CATHETER

Device Problems Detachment Of Device Component (1104); No Flow (2991)

Patient Problem Device Embedded In Tissue or Plaque (3165)

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 catheter would not drain.The nurse tried to deflate the balloon; however, no water returned.When the catheter was removed, the tip of the catheter allegedly remained inside of the patient.After urological consultation, it was recommended that the patient undergo a cystoscopy post discharge to confirm if the suspected piece remained.The patient was discharged with a new catheter.It is unknown at this time if the patient sought medical attention post discharge.

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 catheter would not drain.The nurse tried to deflate the balloon; however, no water returned.When the catheter was removed, the tip of the catheter allegedly remained inside of the patient.After urological consultation, it was recommended that the patient undergo a cystoscopy post discharge to confirm if the suspected piece remained.The patient was discharged with a new catheter.It is unknown at this time if the patient sought medical attention post discharge.

Manufacturer Narrative

Received 1 used silicone catheter with the patient sticker only.Per visual inspection, the inflation valve was cut off and not returned; further inspection noted the tip was missing.The cut area of the catheter (tip) appeared to be a clean cut.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "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).

Event Description

It was reported that the catheter would not drain.The nurse tried to deflate the balloon; however, no water returned.When the catheter was removed, the tip of the catheter allegedly remained inside of the patient.After urological consultation, it was recommended that the patient undergo a cystoscopy post discharge to confirm if the suspected piece remained.The patient was discharged with a new catheter.It is unknown at this time if the patient sought medical attention post discharge.

• Brand Name: SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6575203
• MDR Text Key: 75441306
• Report Number: 1018233-2017-02461
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2017
• Initial Date FDA Received: 05/18/2017
• Supplement Dates Manufacturer Received: Not provided; 08/10/2017
• Supplement Dates FDA Received: 06/12/2017; 08/30/2017
• 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
• Patient Outcome(s): Other
• Patient Age: 54 YR