MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, SINGLE-LUMEN, 9.6F; CHRONIC CATHETERS

Model Number 0600560

Device Problems Fracture (1260); Material Integrity Problem (2978)

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

Event Date 05/01/2023

Event Type  malfunction  

Manufacturer Narrative

H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.H10: d4 (expiry date: 11/2026) 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.

Event Description

It was reported that during a chronic catheter placement procedure, when the catheter was attempted to be inserted into the sheath, the catheter was allegedly found to be damaged.It was further reported that the catheter was removed and stopped inserting.There was no reported patient injury.

Event Description

It was reported that during a chronic catheter placement procedure, when the catheter was attempted to be inserted into the sheath, the catheter was allegedly found to be damaged.It was further reported that the catheter was removed and stopped inserting.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 hickman s/l catheter was received for evaluation.Visual, microscopic, tactile and functional evaluation were performed.A partial diagonal break was noted from the distal end of the tissue cuff.The edges of the partial diagonal break were noted to be uneven and the surface were noted to be round and smooth in both break regions.Therefore, the investigation is confirmed for the identified fracture issue.However, the investigation is unconfirmed for the reported material integrity issue as the specific damage such as fracture was identified during the investigation.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.H10: d4 (expiration date: 11/2026), g3, h6 (device, method) h11: h6 (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.

• Brand Name: HICKMAN CV CATHETER, SINGLE-LUMEN, 9.6F
• 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: 17015400
• MDR Text Key: 316090045
• Report Number: 3006260740-2023-02153
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051845
• UDI-Public: (01)00801741051845
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0600560
• Device Catalogue Number: 0600560
• Device Lot Number: HUHN1284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2023
• 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