MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 HICKMAN CV CATHETER, TRIPLE-LUMEN REPAIR KIT, COMPLETE EXTERNAL SEGMENTS, 10F; PORT AND CATHETER ACCESSORIES

Model Number 0601790

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 07/18/2022

Event Type  malfunction  

Event Description

It was reported that prior to a port placement procedure, the instructions were allegedly missing from the label.There was no patient contact.

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, a photo was provided for review.The investigation of the reported event is currently underway.Expiration date: 07/2023.

Manufacturer Narrative

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: although physical device was not returned for evaluation.One photo was provided for review.The photo shows a label of a repair kit with catalog, lot number and expiry date.Based on the provided photo, the reported issue cannot be confirmed.Therefore, the investigation is inconclusive for the reported failure as the issue could not be confirmed.A 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.Instructions for use states that, ¿catheter preparation (for all catheter repairs) note: stent(s) have been pre-mounted into the replacement segment to facilitate catheter repair.1.Assemble supplies.2.Clean the external segment of the catheter with antiseptic and gauze and place cleaned segment on a sterile drape.Using sterile technique: 3.Wash hands thoroughly.Put on sterile gloves.If using powdered gloves, wipe powder from gloves with alcohol and 4 in.X 4in.(10 cm x 10 cm) gauze.4.Create a sterile field with drapes.5.Remove plunger from syringe barrel, inject medical adhesive into syringe barrel, insert plunger, and attach blunt needle.6.Reposition atraumatic clamp near the skin exit site.7.Cut the external portion of the damaged catheter at a 90° angle just distal to the damaged area.Warnings on the adhesive tube: warning suspected of damaging fertility or the unborn child.Obtain special instructions before use.Do not handle until all safety precautions have been read and understood.Wear protective gloves/protective clothing/ high protection/ face protection.If exposed or concerned: get medical advice/ attention.Liveo¿ medical adhesive silicone, type a bulk safety data sheet: hazards: suspected of damaging fertility or the unborn child.Precautionary statements: prevention: obtain special instructions before use.Do not handle until all safety precautions have been read and understood.Wear protective gloves/ protective clothing/ eye protection/ face protection.Response: if exposed or concerned: get medical advice/ attention.Storage: store locked up.Disposal: dispose of contents/container to an approved waste disposal plant.Individual protection measures: eye/face protection: use safety glasses (with side shields).Skin protection hand protection: use gloves chemically resistant to this material when prolonged or frequently repeated contact could occur.Examples of preferred glove barrier materials include: butyl rubber.Neoprene.Nitrile/butadiene rubber ("nitrile" or "nbr").Ethyl vinyl alcohol laminate ("eval").Polyvinyl alcohol ("pva").Polyvinyl chloride ("pvc" or "vinyl").Viton.Examples of acceptable glove barrier materials include: natural rubber ("latex").Notice: the selection of a specific glove for a particular application and duration of use in a workplace should also take into account all relevant workplace factors such as, but not limited to: other chemicals which may be handled, physical requirements (cut/puncture protection, dexterity, thermal protection), potential body reactions to glove materials, as well as the instructions/specifications provided by the glove supplier.Other protection: when prolonged or frequently repeated contact could occur, use protective clothing chemically resistant to this material.Selection of specific items such as faceshield, boots, apron, or full-body suit will depend on the task.D4 (expiration date: 07/2023).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 : device not returned.

Event Description

It was reported that prior to a procedure, the instruction was allegedly missing from label.There was no patient contact.

• Brand Name: HICKMAN CV CATHETER, TRIPLE-LUMEN REPAIR KIT, COMPLETE EXTERNAL SEGMENTS, 10F
• Type of Device: PORT AND CATHETER ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15264422
• MDR Text Key: 305346247
• Report Number: 3006260740-2022-03261
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036514
• UDI-Public: (01)00801741036514
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K830406
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0601790
• Device Catalogue Number: 0601790
• Device Lot Number: REEZ1887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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