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

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

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

Event Date 06/13/2022

Event Type  Injury  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.No potential root cause could be concluded due to insufficient information.The device was not returned for evaluation.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labeling review due to unknown product code.Although the product family was unknown, the foley catheter product ifus were found to be adequate based on past reviews.

Event Description

It was reported that the patient wanted to know what the tubing on their overnight bag was made from.Representative explained the tubing was pvc.Patient reluctantly admitted they were allergic to latex and were having a lot of pain from the catheter as well as multiple urinary tract infections.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 ¿materials of construction are not biocompatible".The lot number was unknown; therefore, the device history record could not be reviewed.The product catalog number for this device is unknown.Therefore, bd is unable to determine the associated labeling to review.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.

Event Description

It was reported that the patient wanted to know what the tubing on their overnight bag was made from.Representative explained the tubing was pvc.Patient reluctantly admitted they were allergic to latex and were having a lot of pain from the catheter as well as multiple urinary tract infections.It was unknown what medical intervention was provided.Per follow-up via phone (b)(6) 2022, patient was still experiencing pain with use of the foley catheter but did not have the product information to definitely identify the product catalog or lot numbers at this time.Customer also unsure if the catheter was latex or silicone but per initial report from mis, it appeared silicone.No medical intervention was reported.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the patient wanted to know what the tubing on their overnight bag was made from.Representative explained the tubing was pvc.Patient reluctantly admitted they were allergic to latex and were having a lot of pain from the catheter as well as multiple urinary tract infections.It was unknown what medical intervention was provided.Per follow-up via phone 08july2022, patient was still experiencing pain with use of the foley catheter but did not have the product information to definitely identify the product catalog or lot numbers at this time.Customer also unsure if the catheter was latex or silicone but per initial report from mis, it appeared silicone.No medical intervention was reported.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: UNKNOWN ALL SILICONE 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: 14886136
• MDR Text Key: 295125446
• Report Number: 1018233-2022-05062
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• 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