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

Catalog Number	33420
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Iit was reported that the foley catheter probe design was defective as it was missing a plastic part in the part where the balloon was inflated, the washer that indicates the measurement of the probe and lot was missing.The catheter package was not opened and was not used on the patient.As per the additional information received on 19mar2024, the customer confirmed that the washer was not broken but it did not come.
Additional 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.
Event or Problem Description
It was reported that the foley catheter probe design was defective as it was missing a plastic part in the part where the balloon was inflated, the washer that indicates the measurement of the probe and lot was missing.The catheter package was not opened and was not used on the patient.As per the additional information received on 19mar2024, the customer confirmed that the washer was not broken but it did not come.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual received 1 silastic foley catheter in original closed packaging.Upon opening packaging, it was noted the inflation cap was missing.Using in house leur lock syringe the catheter was inflated with 10 ml methylene blue solution (3 drops 1 percentage aqueous methylene blue per 100ml distilled water).And deflated properly with no difficulties.Also received 3 photo samples.First photo sample shows product material number details on product packaging.Second photo sample shows top view of catheter encased within packaging.Third photo sample zooms in on bifurcation site with inflation cap missing.Therefore, based on photo and physical sample received the reported event is confirmed.This does not meet specification which state "missing/incorrect components are not allowed".The exact root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be "improper tolerancing (fit between the check valve/cap assembly and inflation funnel".However, there was insufficient information to confirm this potential root cause.The reported event is addressed and the residual risk for this event is low.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The labelling review is not required as labelling would not have prevented the reported event.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.

• Brand Name: BARD® SILASTIC® FOLEY CATHETER
• Common Device Name: FOLEY 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19051825
• Report Number: 1018233-2024-01906
• Device Sequence Number: 18151936
• Product Code: EZL
• UDI-Device Identifier: 00801741020001
• UDI-Public: (01)00801741020001
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K951103
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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 Expiration Date: 03/31/2026
• Device Catalogue Number: 33420
• Device Lot Number: NGHS2608
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/16/2023
• 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