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

Model Number	N/A
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Malfunction
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 will evaluate.Results are expected soon.
Event or Problem Description
It was reported that bard port access kits tegaderm do not stick to patient skin to prevent infection.In fact it is not securely adhered to the packaging either.This is all the kits, requiring using a #m tegaderm.Lot number is rehy1908.There was not any patient impact.No other information was provided.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 complaint of a dressing not adhering to a patient¿s skin is inconclusive because the clinical factors could not be reproduced.One dressing was returned for evaluation.An initial visual observation revealed some use residues along the returned device.The backing was observed to be sufficiently attached to the device.A small wrinkle was observed on one corner of the dressing.A tactile evaluation of the dressing revealed the backside of the device was observed to be tacky.A tactile evaluation of a non-complainant dressing was observed to be slightly tackier than the returned product.A functional test of attempting to stick the returned dressing to a fake skin revealed the dressing stuck; however, the fake skin does not accurately replicate the oils on real human skin.Because the returned dressing had wrinkles along its surface, it is not known whether attempts were made to use the device.Due to unknown usage of the device and unknown environmental factors, the complaint of difficult adhesion of a dressing to a patient is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported that bard port access kits tegaderm do not stick to patient skin to prevent infection.In fact, it is not securely adhered to the packaging either.This is all the kits, requiring using a #m tegaderm.Lot number is rehy1908.There was not any patient impact.No other information was provided.A specific number of affected devices or patients was not provided by the complainant.

• Brand Name: POWERLOC 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19184429
• Report Number: 3006260740-2024-01924
• Device Sequence Number: 15240767
• Product Code: FPA
• UDI-Device Identifier: 00801741044472
• UDI-Public: (01)00801741044472
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060812
• 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): 06/25/2024

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: 03/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 2652034
• Device Lot Number: REHY1908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 07/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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 Age: 77 YR
• Patient Sex: Male