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

Device Problem Incorrect Measurement (1383)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/30/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the solasic catheters were too thin and stretched out, so they were loose in the statlock.The user had to stuff toilet paper or tissue in it.Per follow up information received on 05sep2021, stated the foley catheter was too thin and appeared to be stretched with white stretch markings just below where the sample ports connection junction was located.When the user placed the catheter into the statlock, it slides and pulls through so they used toilet paper or tissue to prevent this from happening.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect catheter buildup and/or finish dipping".It was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.A dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - 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.H3 other text : the device was not returned.

Event Description

It was reported that the solasic catheters were too thin and stretched out, so they were loose in the statlock.The user had to stuff toilet paper or tissue in it.Per follow up information received on 05sep2021, stated the foley catheter was too thin and appeared to be stretched with white stretch markings just below where the sample ports connection junction was located.When the user placed the catheter into the statlock, it slides and pulls through so they used toilet paper or tissue to prevent this from happening.

• Brand Name: LATEX FOLEY CATHETER
• Type of Device: UNKNOWN FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12525403
• MDR Text Key: 273091975
• Report Number: 1018233-2021-05929
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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