MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®

Model Number	A903316A
Medical Device Problem Code	Illegible Information (4050)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that the patient had latex allergy due to latex foley placed in the patient.Representative could not find any indication on foley package documenting latex product.Relief representative removed the foley immediately before procedure began, because they knew from experience this product was in fact a latex product.Patient sustained no harm.Surgeon opted to drain bladder with in and out catheter at the end of procedure rather than placing a non-latex foley.After examining other foley catheter kits the required documentation of latex product was found on the kit, but the flap seal was covering the writing from immediately being seen, a person would have to know where to look and maneuver the product inside.Some of the kits had an additional sticker placed on them that said this product contains latex, but all kits did not have a sticker.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be ¿incorrect/ missing translation; missing instructions; vendor/printer error." it was unknown whether the device had met specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The instructions for use were found adequate and states the following: it states "caution: this product contains natural rubber latex which may cause allergic reactions.Warning: do not use if allergic to iodine." 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 or Problem Description
It was reported that the patient was latex allergy, latex foley placed in patient.Representative could not find any indication on foley package documenting latex product.Relief representative removed the foley immediately before procedure began, because they knew from experience this product was in fact a latex product.Patient sustained no harm.Surgeon opted to drain bladder with in and out catheter at the end of procedure rather than placing a non-latex foley.After examining other foley catheter kits the required documentation of latex product was found on the kit, but the flap seal was covering the writing from immediately being seen, a person would have to know where to look and maneuver the product inside.Some of the kits had an additional sticker placed on them that said this product contains latex, but all kits did not have a sticker.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARDEX® IC COMPLETE CARE®
• Common Device Name: 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: 16466954
• Report Number: 1018233-2023-01383
• Device Sequence Number: 20767859
• Product Code: MJC
• UDI-Device Identifier: 00801741096600
• UDI-Public: (01)00801741096600
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2023

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
• Operator of Device: Health Professional
• Device Model Number: A903316A
• Device Catalogue Number: A903316A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/10/2023
• Supplement Date Received by Manufacturer: 04/12/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown