MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, DUAL-LUMEN, 9F; CHRONIC CATHETER

Model Number	0600600
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that some time post chronic catheter placement procedure, the catheter allegedly fractured.It was further reported that the catheter allegedly leaked from the bifurcation site.There was no reported patient injury.
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.However, a photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 02/2025).Device pending return.
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 hickman d/l catheter was returned for evaluation.Functional, gross visual, and microscopic visual evaluations were performed.A complete circumferential break was noted approximately 2.9cm from the distal end of the y-body.However, striations were noted throughout.Although, a sample was received, one photo was provided for review.The photo shows a d/l catheter held by a clinician.A fracture was noted near the y-body.Based on the provided photo, the reported fracture and fluid leak issues can be confirmed.Therefore, the investigation is confirmed for the reported fracture and fluid leak issues, as a longitudinal break was noted just distal of the y-body.A definitive root cause could not be determined based upon the 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.H10: d4 (expiry date: 02/2025).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 that approximately two months post chronic catheter placement procedure, the catheter was allegedly fractured.It was further reported that the catheter allegedly leaked from the bifurcation site.Reportedly, the device was removed and replaced.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN, 9F
• Common Device Name: CHRONIC CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15299867
• Report Number: 3006260740-2022-03325
• Device Sequence Number: 2467611
• Product Code: LJS
• UDI-Device Identifier: 00801741051890
• UDI-Public: (01)00801741051890
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

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 Model Number: 0600600
• Device Catalogue Number: 0600600
• Device Lot Number: HUFT1047
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 10/10/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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