MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC HF CATHETER W/ SHERLOCK 3CG (TPS) STYLET (5F) (TL); 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	07/11/2023
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 by customer that item within gauze in sterilized packaging.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.
Event or Problem Description
It was reported by customer that item within gauze in sterilized packaging.Additional information received via medwatch 08/22/2023: a bedside picc was placed in 2 ls (site name) yesterday evening.At the end of the procedure the app (advanced practice provider) was throwing the gauze away and she saw a weird dark spot in the center of the gauze pile (pic was sent in email to ic, [redacted name] and risk management).It was malodourous as well.I have the actual gauze if there is any interest.After discussing with her supervising attendings, a decision was made to pull the picc and place a new one on the other side.The icu team and nurse manager were made aware, as well as the hcp.We do not use all the gauze supplied in the pack during a picc line (related to low ebl) so we are confident that it didn¿t come in to contact with anything.But, we of course still have concerns.
Event or Problem Description
It was reported by customer that item within gauze in sterilized packaging.Additional information received via medwatch on 08/22/2023: a bedside picc was placed in 2 ls (site name) yesterday evening.At the end of the procedure the app (advanced practice provider) was throwing the gauze away and she saw a weird dark spot in the center of the gauze pile (pic was sent in email to ic, [redacted name] and risk management).It was malodourous as well.I have the actual gauze if there is any interest.After discussing with her supervising attendings, a decision was made to pull the picc and place a new one on the other side.The icu team and nurse manager were made aware, as well as the hcp.We do not use all the gauze supplied in the pack during a picc line (related to low ebl) so we are confident that it didn¿t come in to contact with anything.But, we of course still have concerns.
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.Based on a review of available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of material found on the gauze in the catheter kit was confirmed; however, the root cause was not identified.The product returned for evaluation was a piece of gauze, reportedly from a powerpicc catheter tray.The gauze was not neatly folded and appeared to have been manipulated.A brown mass of unidentified material was present and appeared to have discolored several sections of the gauze.Microscopic inspection of the gauze confirmed the presence of material.The material was reddish-brown in color and appeared comprised of fibers consistent with those making up the gauze.While material was found on the gauze, the opened state of the packaging and manipulated condition of the gauze prevented determination of the state of the sample when initially received by the complainant.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.H3 other text: evaluation findings are in section h11.

• Brand Name: POWERPICC HF CATHETER W/ SHERLOCK 3CG (TPS) STYLET (5F) (TL)
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17424583
• Report Number: 3006260740-2023-03242
• Device Sequence Number: 7721286
• Product Code: LJS
• UDI-Device Identifier: 00801741144776
• UDI-Public: (01)00801741144776
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K091324
• 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,Followup
• Report Date (Section B): 10/27/2023

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: 02/29/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000795
• Device Lot Number: REGW2592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/22/2023; 10/27/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/29/2023; 10/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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 Age: 62 YR
• Patient Sex: Female