MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LUBRI-SIL COMPREHENSIVE CARE FOLEY TRAYS; PRECONNECTED FOLEY TRAY

Catalog Number D17585L12

Device Problem Wrong Label (4073)

Patient Problems Hypersensitivity/Allergic reaction (1907); Nausea (1970); Swelling/ Edema (4577)

Event Date 07/04/2023

Event Type  Injury  

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 district nurse attended to fit patients foley catheter.After an hour or so, patient was feeling very unwell and nauseous.Patients bladder had swollen and they were feeling sick.District nurse returned to change patients catheter and found that the catheter fitted was in fact a latex catheter that had been packaged in a silicone catheter box.The patient had reacted because they had a latex allergy.It was stated that if the district nurse had not been able to get back as soon as they did, the patient would have been hospitalized.District nurse had to re-attend due to the allergic reaction to the incorrectly packaged latex catheter.It was unknown what medical intervention was provided.

Event Description

It was reported that the district nurse attended to fit patients foley catheter.After an hour or so, patient was feeling very unwell and nauseous.Patients bladder had swollen and they were feeling sick.District nurse returned to change patients catheter and found that the catheter fitted was in fact a latex catheter that had been packaged in a silicone catheter box.The patient had reacted because they had a latex allergy.It was stated that if the district nurse had not been able to get back as soon as they did, the patient would have been hospitalized.District nurse had to re-attend due to the allergic reaction to the incorrectly packaged latex catheter.It was unknown what medical intervention was provided.

Manufacturer Narrative

Upon further review, bd has determined that this mdr event is not reportable.As there is no us equivalent for this pcn.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: LUBRI-SIL COMPREHENSIVE CARE FOLEY TRAYS
• Type of Device: PRECONNECTED FOLEY TRAY
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 17376717
• MDR Text Key: 319715337
• Report Number: 1018233-2023-05413
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

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
• Device Catalogue Number: D17585L12
• Device Lot Number: NGGS0475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/04/2023
• Initial Date FDA Received: 07/24/2023
• Supplement Dates Manufacturer Received: 09/14/2023
• Supplement Dates FDA Received: 10/05/2023
• 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; Required Intervention
• Patient Sex: Male