MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
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, "a piece of human hair has been found in the package after opened so the product was considered as contamination and can't be used, then the new one had to be replaced.".
Additional Manufacturer Narrative
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 hair present within the kit tray is inconclusive due to poor sample condition.Two photo samples of a powerpicc catheter kit were provided for evaluation.The first image showed a product sticker label depicting lot: regz0433.The second image showed an open 5 fr powerpicc catheter kit tray.The catheter, guidewire, and introducer needle are present within the tray.A hair appears to be present partially within the tray extending past the tray flange.The condition of the kit tray contents prior to kit opening and handling remains unknown; therefore, the complaint could not be confirmed and remains inconclusive at this time.
Event or Problem Description
It was reported that, "a piece of human hair has been found in the package after opened so the product was considered as contamination and can't be used, then the new one had to be replaced.".
Event or Problem Description
It was reported that, "a piece of human hair has been found in the package after opened so the product was considered as contamination and can't be used, then the new one had to be replaced.".
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 foreign material is confirmed; however, the root cause could not be determined.The product returned for evaluation was a 5fr dual lumen powerpicc catheter, a 5fr microintroducer, a 21ga introducer needle, an ir guidewire, and two end caps.The kit tray was received partially opened.A hair was found in the kit tray.Also received was a photograph of the opened kit which also showed a hair within the kit tray.Due to the open state of the kit, it could not be determined when the hair entered¬ the kit tray.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h11.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER RADIOLOGY BASIC TRAY
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: 16933863
• Report Number: 3006260740-2023-01901
• Device Sequence Number: 6235507
• Product Code: LJS
• UDI-Device Identifier: 00801741027949
• UDI-Public: (01)00801741027949
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/29/2024

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 3275335
• Device Lot Number: REGZ0433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2023
• Supplement Date Received by Manufacturer: 08/14/2023; 04/29/2024
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 08/17/2023; 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/01/2022
• 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