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

Model Number	A304416A
Medical Device Problem Codes	Partial Blockage (1065); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.No potential root cause could be concluded due to insufficient information.The lot number was unknown; therefore, the device history record could not be reviewed.Unable to perform labelling 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 or Problem Description
It was reported that the substitute foley catheters were clogging and were having to be replaced.It was stated that the staffs were thinking they were isolated incidents until they started comparing notes and realized there so many issues.The nurses had been asked to fill out safety reports on the patients that had needed their foley replaced.Also stated that one nurse alone had about 3 to replace over the last week.It was also stated that the customer was having trouble in identifying the model number and the only identifying information that the customer got from the staffs was that the image of the bag that had a different clamp than normal surestep trays.Per additional information received on 05oct2021, it was reported that the foley had clogging and the patient safety reports were filed but no patient harm was reported.Customer confirmed only 3 incidents that were reported to them.They were using bard foley care kits, substitute for the surestep trays and could not identify which trays were in each department at the time of the incidents.
Event or Problem Description
It was reported that the substitute foley catheters were clogging and were having to be replaced.It was stated that the staffs were thinking they were isolated incidents until they started comparing notes and realized there so many issues.The nurses had been asked to fill out safety reports on the patients that had needed their foley replaced.Also stated that one nurse alone had about 3 to replace over the last week.It was also stated that the customer was having trouble in identifying the model number and the only identifying information that the customer got from the staffs was that the image of the bag that had a different clamp than normal surestep trays.Per additional information received on 05oct2021, it was reported that the foley had clogging and the patient safety reports were filed but no patient harm was reported.Customer confirmed only 3 incidents that were reported to them.They were using bard foley care kits, substitute for the surestep trays and could not identify which trays were in each department at the time of the incidents.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.H11: section a through f - the information provided by bard 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 bard.The device was not returned.

• Brand Name: LATEX FOLEY CATHETER
• Common Device Name: LATEX 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12616846
• Report Number: 1018233-2021-06358
• Device Sequence Number: 19166731
• Product Code: EZC
• UDI-Device Identifier: 00801741104206
• UDI-Public: (01)00801741104206
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• 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): 11/01/2021

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: A304416A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/17/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 11/19/2021
• 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