MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SAFESTEP PORT ACCESS KIT 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Defective Component (2292); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer rn was accessing portacath, opened a bard kit to use.When she peeled the backing of the adhesive dressing, two rns noticed a white spot on the inside of the dressing/sticky side.A new dressing was opened.No other information was provided.
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 manufacturer has received the sample and is pending evaluation.Results are expected soon.
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.He complaint of material deformation found along the dressing is confirmed, but the exact cause could not be determined.One adhesive dressing was returned for evaluation.An initial visual observation showed no obvious use residues throughout the returned dressing.The backing was observed to be attached to the back of the device.A small bubble in the clear section of the dressing was circled in pink.A microscopic observation revealed the small bubble appeared to be circular with a clearly defined indentation around the bubble.The backing of the device was peeled back to observe the color of the bubble.The bubble appeared white due to the wrinkling of what appeared to be the clear portion of the device.The bubble was observed to be deformation of the clear portion of the device.Because the device was returned opened but a bubble could be observed on the dressing, the complaint of deformation found on the device is confirmed, but the root cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer rn was accessing portacath, opened a bard kit to use.When she peeled the backing of the adhesive dressing, two rns noticed a white spot on the inside of the dressing/sticky side.A new dressing was opened.No other information was provided.

• Brand Name: SAFESTEP PORT ACCESS KIT 20G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19288299
• Report Number: 3006260740-2024-02280
• Device Sequence Number: 8739634
• Product Code: FPA
• UDI-Device Identifier: 00801741085529
• UDI-Public: (01)00801741085529
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• 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,Followup
• Report Date (Section B): 06/26/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: PA-0031
• Device Lot Number: REHW1998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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