MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 INTERMITTENT ROCHESTER CATHETERS; INTERMITTENT CATHETER

Model Number	50812G
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Sepsis (2067)
Date of Event	05/22/2023
Type of Reportable Event	Serious Injury
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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that these intermittent catheters caused patient an infection and was hospitalized and caught tetanus.It was unknown what medical intervention was provided for infection and tetanus.Per follow up via phone on 22may2023, it was reported that the customer received a voluntary emergency notice from bd regarding a recall for a nonconformity with the magic go 14 fr catheters.They were reported in a company-wide notice as having nonsterile coude, and they happened to be one of those impacted by it.At the time, they were sent out from 180 medical.This led to numerous bladder infections and sepsis, and this made things difficult for them as they could not walk.They still had samples available and provided the lot# jugw1445.
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.H3 other text: the device was not returned.
Event or Problem Description
It was reported that these intermittent catheters caused patient an infection and was hospitalized and caught tetanus.It was unknown what medical intervention was provided for infection and tetanus.Per follow up via phone on 22may2023, it was reported that the customer received a voluntary emergency notice from bd regarding a recall for a nonconformity with the magic go 14 fr catheters.They were reported in a company-wide notice as having nonsterile coude, and they happened to be one of those impacted by it.At the time, they were sent out from 180 medical.This led to numerous bladder infections and sepsis and this made things difficult for them as they could not walk.They still had samples available and provided the lot#: jugw1445.
Event or Problem Description
It was reported that these intermittent catheters caused patient an infection and was hospitalized and caught tetanus.It was unknown what medical intervention was provided for infection and tetanus.Per follow up via phone on (b)(6) 2023, it was reported that the customer received a voluntary emergency notice from bd regarding a recall for a nonconformity with the magic go 14 fr catheters.They were reported in a company-wide notice as having nonsterile coude, and they happened to be one of those impacted by it.At the time, they were sent out from 180 medical.This led to numerous bladder infections and sepsis, and this made things difficult for them as they could not walk.They still had samples available and provided the lot#: jugw1445.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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.

• Brand Name: INTERMITTENT ROCHESTER CATHETERS
• Common Device Name: INTERMITTENT 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: 17134183
• Report Number: 1018233-2023-04345
• Device Sequence Number: 6448720
• Product Code: EZD
• UDI-Device Identifier: 00801741137013
• UDI-Public: (01)00801741137013
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K150345
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2023

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
• Operator of Device: Lay User/Patient
• Device Model Number: 50812G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2023
• Supplement Date Received by Manufacturer: 06/21/2023; 09/28/2023
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 07/18/2023; 10/04/2023
• 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: Male