MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN TRIFUSION CV CATHETER, TRIPLE-LUMEN, 12F; CHRONIC CATHETERS

Catalog Number	0609230
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sometime post catheter placement procedure, the cuff was allegedly couldn't found and also a piece of plastic was found near the site.Reportedly, everything was successfully removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H10: d4 (expiry date: 03/2025).H11: section a through f ¿ the information provided by bd represents all 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.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 23cm trifusion t/l catheter was returned for evaluation.Functional, gross visual and tactile evaluations were performed.The tissue cuff was not present on the catheter.Therefore, the investigation is confirmed for the reported loss or failure to bond and identified improper procedure issue.The definitive root cause could not be determined based upon available information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The instructions for use was reviewed and it states, precautions: ¿ carefully read and follow all instructions prior to use.¿ only qualified healthcare practitioners should insert, manipulate and remove these devices.H10: d4 (expiry date: 03/2025).H11: section a through f ¿ the information provided by bd represents all 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 that approximately six months post a chronic catheter placement, the cuff was allegedly couldn't be found and also a piece of plastic was found near the site.Reportedly, everything was successfully removed.There was no reported patient injury.
Event or Problem Description
It was reported that approximately six months post a chronic catheter placement, the cuff was allegedly couldn't be found and also a piece of plastic was found near the site.Reportedly, everything was successfully removed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 23cm trifusion t/l catheter was returned for evaluation.Functional, gross visual and tactile evaluations were performed.The tissue cuff was not present on the catheter.Therefore, the investigation is confirmed for the reported loss or failure to bond and identified improper procedure issue.However the investigation is inconclusive for the reported difficult to remove issue as the exact circumstances at the time of reported event was unknown.Although the definitive root cause for the reported loss or failure to bond issues could not be determined based upon available information, the root cause for the improper procedure issue was determined to be use error.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.The instructions for use states, precautions: carefully read and follow all instructions prior to use.Only qualified healthcare practitioners should insert, manipulate and remove these devices.Catheter removal: the white retention cuff facilitates tissue in-growth.The catheter must be surgically removed.Free the cuff from the tissue and pull the catheter gently and smoothly.H10: h6 (device).H11: h6 (conclusion).H11: section a through f ¿ the information provided by bd represents all 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.

• Brand Name: HICKMAN TRIFUSION CV CATHETER, TRIPLE-LUMEN, 12F
• Common Device Name: CHRONIC CATHETERS
• 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: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18282049
• Report Number: 3006260740-2023-05564
• Device Sequence Number: 12474200
• Product Code: LJS
• UDI-Device Identifier: 00801741036538
• UDI-Public: (01)00801741036538
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K041088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2024

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 Catalogue Number: 0609230
• Device Lot Number: REHR0933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/13/2023
• Supplement Date Received by Manufacturer: 02/05/2024; 07/16/2024
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 02/20/2024; 07/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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
• Patient Sex: Unknown