MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL FOLEY CATHETERS

Device Problem Calcified (1077)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

It was reported that survey respondent mentioned bacteriuria, symptomatic urinary tract infection, pain, catheter blockage and leakage when they were asked of complications while using the bard lubrisil hydrogel coated silicone foley catheter (d17615m (12-16)).It was unknown what medical intervention was provided.As per additional information received on (b)(6) 2022, the survey respondent also mentioned urethral or bladder trauma and bladder stones when asked of complications while using the bard lubrisil hydrogel coated silicone foley catheter (d17615m (12-16)).

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 survey respondent mentioned bacteriuria, symptomatic urinary tract infection, pain, catheter blockage and leakage when they were asked of complications while using the bard lubrisil hydrogel coated silicone foley catheter (d17615m (12-16)).It was unknown what medical intervention was provided.As per additional information received on 26may2022, the survey respondent also mentioned urethral or bladder trauma and bladder stones when asked of complications while using the bard lubrisil hydrogel coated silicone foley catheter (d17615m (12-16)).

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿inadequate process".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "do not use if package is damaged.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Sterilized using ethylene oxide.For urological use only.Single use only contains or presence of phthalates: di (2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks." the device was not returned.

• Brand Name: LUBRI-SIL FOLEY CATHETERS
• Type of Device: 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15485881
• MDR Text Key: 303795345
• Report Number: 1018233-2022-07354
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2022
• Initial Date FDA Received: 09/26/2022
• Supplement Dates Manufacturer Received: 10/12/2022
• Supplement Dates FDA Received: 10/13/2022
• 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