MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE SCRUB IPA STERILE; PAD, ALCOHOL, DEVICE DISINFECTANT

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that there is increase in failing membranes on their tego connectors.The customer uses tego needless connectors on all hemodialysis lines.They started using safescrub and sitescrub in a trial and have noticed an increase in failing membranes on their tego connectors.They believe its attributed to the "vigorous" scrubbing of the bd disinfectant caps.Follow up response received o 19/08/2024 it¿s happening at random on a few different occasions and across several lot numbers.The event was during patient use.There was no patient injury but the nurses had to change their tego connectors out which was an additional workload to them.The bd product is not damaged.The damage was to the tego needless connector.The customer believes our scrub cap caused damage to the membrane due to the foam fingers and ¿vigorous¿ scrub of the device.A specific number of affected devices or patients was not provided by the complainant.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The device has not been returned to the manufacturer for evaluation.

• Brand Name: SITE SCRUB IPA STERILE
• Common Device Name: PAD, ALCOHOL, DEVICE DISINFECTANT
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20200814
• Report Number: 3006260740-2024-05157
• Device Sequence Number: 7518120
• Product Code: LKB
• UDI-Device Identifier: 10801741086943
• UDI-Public: (01)10801741086943
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K112791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/24/2024

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 Model Number: N/A
• Device Catalogue Number: 3882100
• Device Lot Number: UNKNOWN
• 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: 08/14/2024
• Initial Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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