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

Catalog Number	0600580
Medical Device Problem Codes	Backflow (1064); Burst Container or Vessel (1074); Fracture (1260); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: 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.The investigation of the reported event is currently underway.H10: d4 (expiry date: 08/2024).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 seven months and sixteen days post a chronic catheter placement, the catheter allegedly found to be ballooned approximately one month post placement.It was further reported that blood backflow allegedly occurred at the small lumen.Reportedly, a small fracture was allegedly noticed while flushing.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 9f hickman d/l catheter was returned for evaluation along with one electronic photo.Functional, gross visual, tactile, microscopic visual evaluation were performed on the returned device.A longitudinal split was noted on the white luer extension leg.In photo review split was noted on white luer and on the red color extension leg ballooned shape was noted.Therefore, the investigation is confirmed for the reported fracture, stretch and material protrusion issues.However, the investigation is inconclusive for the reported backflow as no objective evidence to confirm this was provided for review.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 08/2024), g3 h11: h6 (method, result, 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.
Event or Problem Description
It was reported that seven months and sixteen days post a chronic catheter placement, the catheter allegedly found to be ballooned approximately one month post placement.It was further reported that blood backflow allegedly occurred at the small lumen.Reportedly, a small fracture was allegedly noticed while flushing.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one 9f hickman d/l catheter was returned for evaluation along with one electronic photo.Visual, microscopic visual, tactile and functional evaluations were performed on the returned device.A longitudinal split was noted on the white luer extension leg and edges appeared jagged.In the photo review split was noted on white luer and on the red color extension leg ballooned shape was noted.Upon infusion, a leak from the longitudinal split was noted from the extension white leg.Thrombus was noted exiting from the split and distal end of the catheter.Aspiration was attempted and was unsuccessful.The catheter felt abnormally elastic when it was gently pulled and stretched.Therefore, the investigation is confirmed for the reported burst, stretch, material protrusion and backflow issue.The definitive root cause could not be determined based upon available information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: d4 (expiration date: 08/2024).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 seven months and sixteen days post a chronic catheter placement, the catheter allegedly found to be ballooned approximately one month post placement.It was further reported that blood backflow allegedly occurred at the small lumen.Reportedly, a small burst was allegedly noticed while flushing.There was no reported patient injury.

• Brand Name: HICKMAN PEDIATRIC CV CATHETER, DUAL-LUMEN, 9F
• 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 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: 18561907
• Report Number: 3006260740-2024-00144
• Device Sequence Number: 12477157
• Product Code: LJS
• UDI-Device Identifier: 00801741051883
• UDI-Public: (01)00801741051883(17)240828(10)HUEU0621
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2024

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 Catalogue Number: 0600580
• Device Lot Number: HUEU0621
• 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: 12/27/2023
• Supplement Date Received by Manufacturer: 04/03/2024; 09/16/2024
• Initial Report FDA Received Date: 01/23/2024
• Supplement Report FDA Received Date: 04/08/2024; 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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