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

Device Problems Gel Leak (1267); Short Fill (1575)

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

Event Date 08/18/2023

Event Type  malfunction  

Event Description

It was reported that the foley trays were overheated, and the blue wrapper was shrink wrapped tight around the foley and enquired if this compromises sterility and representative responded the ky jelly syringe was empty and some of the blue wrapper was stuck to y-site.It seems as if the foley tray was outside of the proper temperature parameters.Mi cannot recommend using the product as the product or packaging has been compromised.This will have to be a facility decision if they choose to use.

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.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be "tip cover came off during shipping or in processing".The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.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 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 foley trays were overheated, and the blue wrapper was shrink wrapped tight around the foley and enquired if this compromises sterility and representative responded the ky jelly syringe was empty and some of the blue wrapper was stuck to y-site.It seems as if the foley tray was outside of the proper temperature parameters.Mi cannot recommend using the product as the product or packaging has been compromised.This will have to be a facility decision if they choose to use.

• Brand Name: FOLEY TRAYS
• Type of Device: FOLEY TRAYS
• 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: 17754535
• MDR Text Key: 323478094
• Report Number: 1018233-2023-06792
• 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,Consumer,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/20/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 11/06/2023
• Supplement Dates FDA Received: 11/08/2023
• 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
• Patient Sex: Female