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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Urinary Tract Infection (2120); Urinary Incontinence (4572)

Event Date 05/19/2022

Event Type  Injury  

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 respondent mentioned symptomatic urinary tract infection, pain, urethral or bladder trauma, incontinence and accidental removal when asked of complications while using the bard lubri-sil hydrogel coated all-silicone foley catheter.It was unknown what medical intervention was provided.

Event Description

It was reported that the respondent mentioned symptomatic urinary tract infection, pain, urethral or bladder trauma, incontinence and accidental removal when asked of complications while using the bard lubri-sil hydrogel coated all-silicone foley catheter.It was unknown what medical intervention was provided.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿tortuous anatomy".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: "please see reverse side for directions for use 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.This is a single use device.Do not resterilise any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Warning: on catheter, do not use ointments or lubricants having a petroleum base.They will damage the catheter and may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws, regulations, and policies.Caution keep away from sunlight.Do not store at freezing temperatures, keep at room temperature away from direct exposure to light, preferably in original box.Consult instructions for use inflate with 10 ml sterile water do not resterilise." correction: g.H11: section a through f - the information provided by bd represents all 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 bd.H3 other text : the device was not returned.

• Brand Name: UNKNOWN LUBRI-SIL FOLEY CATHETERS
• Type of Device: LUBRI-SIL FOLEY CATHETERS
• 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: 14634458
• MDR Text Key: 293628710
• Report Number: 1018233-2022-04475
• 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,Study
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• 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