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

Model Number	0600580
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2023
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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2025).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.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the label does not allegedly have the information about full length of the catheter.There was no reported patient injury.
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: the physical device was not returned for evaluation.One electronic photo was provided for review.The photo shows one hickman 9f dual lumen cv catheter kit label showing the contents of the kit, catalog number, lot number and expiry date.Therefore, the investigation is unconfirmed for the reported catheter length issue as the tip-to-cuff length (35 cm) is different than total length (65 cm).The 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.The instructions for use was reviewed and the unit label was reviewed which shows, peel-apart introducer kit - contents: ¿ 1 each hickman® pediatric length dual-lumen radiopaque silicone catheter with surecuff¿ tissue ingrowth cuff, 9 f (2.9 mm 00) x 35 cm.H10: d4 (expiration date: 02/2025), g3, h6 (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.
Event or Problem Description
It was reported that during a chronic catheter placement procedure, the label does not allegedly have the information about full length of the catheter.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: 17123762
• Report Number: 3006260740-2023-02422
• Device Sequence Number: 7435012
• Product Code: LJS
• UDI-Device Identifier: 00801741051883
• UDI-Public: (01)00801741051883
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/18/2023

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: 0600580
• Device Catalogue Number: 0600580
• Device Lot Number: HUFT1024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 09/15/2023
• Initial Report FDA Received Date: 06/14/2023
• Supplement Report FDA Received Date: 09/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/13/2021
• 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