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

Model Number 0600600

Device Problems Disconnection (1171); Fracture (1260); Material Separation (1562)

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

Event Date 01/27/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, photo was provided for review.The investigation of the reported event is currently underway.

Event Description

It was reported that post aseptic procedure, the catheter allegedly disconnected near the connector.It was further reported that the catheter was removed two days after disconnection.There was no reported patient injury.

Event Description

It was reported that post asepsis procedure, the catheter allegedly disconnected near the connector.It was further reported that the catheter was removed two days after disconnection.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a complaint history review was performed.This is the fourth complaint reported for this lot number and the lot met all release criteria.A device history record review is required.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for a material separation in the catheter as a separation was noted in the extension leg of the catheter just distal to the catheter hub and also a small proximal catheter segment appears to be attached to the hub in the provided photo.Based upon the available information a definitive root cause could not be determined.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: 09/2023), g3, h6(method).H11: d4(medical device lot number), h6 (device, result, conclusion).H11: section a through f ¿ the information provide 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.H3 other text : device not returned.

• 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
• MDR Report Key: 11647910
• MDR Text Key: 244877837
• Report Number: 3006260740-2021-01278
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051890
• UDI-Public: (01)00801741051890
• Combination Product (y/n): N
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• 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: HUDP1551
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 YR