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

Model Number 0600600

Device Problems Stretched (1601); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

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, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 06/2026).

Event Description

It was reported that during a chronic catheter placement procedure, the catheter was placed in patient but when one lumen was injected the catheter allegedly ballooned up in front of the catheter clamp.It was further reported that the catheter was removed and replaced.There was no reported patient injury.

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 9fr hickman d/l catheter was received for evaluation and two photos were provided for review.Visual, microscopic, tactile and functional evaluations were performed.Upon infusion, ballooning was observed throughout the clamping sleeve.Destructive testing was performed by making a longitudinal split on the white luer extension leg and thrombus was noted inside the extension leg.Therefore, the investigation is confirmed for the reported material protrusion and stretched issues and the photo review also confirms the same.A 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.H10: d4 (expiry date: 06/2026).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.H3 other text : see h10.

Event Description

It was reported that during a chronic catheter placement procedure, the catheter was placed in patient but when one lumen was injected the catheter allegedly ballooned up in front of the catheter clamp.It was further reported that the catheter was removed and replaced.There was no reported patient injury.

• Brand Name: HICKMAN CV CATHETER, DUAL-LUMEN, 9F
• Type of Device: 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: 16740437
• MDR Text Key: 313307121
• Report Number: 3006260740-2023-01322
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051890
• UDI-Public: (01)00801741051890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600600
• Device Catalogue Number: 0600600
• Device Lot Number: HUGP1323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 44 KG