MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 REPLACEMENT CONNECTOR FOR 4F GROSHONG NXT CLEARVUE PICC W/ EXTENSION LEG; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/31/2022

Event Type  Injury  

Event Description

It was reported that the oversleeve portion and the extension tubing were disengaged on the next day after completion of catheter maintenance, leading to the detachment of the catheter into the vessel of the patient.Additional information received: customer reports the distal catheter migrated into the patient's vessel and the proximal end is no longer coming out of the insertion site.There are no plans to retrieve the migrated catheter segment.Customer reports the "patient status is ok".A new catheter has not been placed.It was reported this occurred with two devices.This report addresses the first device.

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of refn1918 showed four other similar product complaint(s) from this lot number.

Manufacturer Narrative

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.The following were reviewed as part of this investigation: patient severity, complaint and batch history, applicable previous investigation(s), applicable manufacturing records, radiographic image analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint that the catheter broke was confirmed but the cause is unknown.Two coned down fluoroscopic images of the right extremity were returned for evaluation of this complaint.The first image did not contain a date while the second image was dated 10/21/2022.A section of a catheter was partially imaged within the returned images.The first image had the catheter tubing over the right axilla extending to the right subclavian region.The second image also has the tubing over the right axilla, but the tubing segment appeared shorter and was not as deep as in the first image.The fine details are limited to evaluate the catheter over the mediastinum but it does appear that there may be something overlaying the mediastinum.The depth and length differences indicated that the catheter likely broke.It was reported that the two-piece connector had become disengaged.However, no images were provided of the connector and the characteristic of the proximal end of the catheter segment could not be seen in the returned images, so this could not be confirmed as the root cause.The returned images did not contain enough information to identify a specific root cause of the reported event.Possible contributing factors for the connectors becoming disengaged could include damage or deformation to the interfacing features of the connectors or an improper dimension on an interfacing component (e.G., distance between locking arms or an over-sized internal compression sleeve).Other possible contributing factors for catheter breaks with embolization could include sharp instrument damage, material fatigue, or tensile (pulling) damage to the catheter shaft.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the oversleeve portion and the extension tubing were disengaged on the next day after completion of catheter maintenance, leading to the detachment of the catheter into the vessel of the patient.Additional information received: customer reports the distal catheter migrated into the patient's vessel and the proximal end is no longer coming out of the insertion site.There are no plans to retrieve the migrated catheter segment.Customer reports the "patient status is ok".A new catheter has not been placed.It was reported this occurred with two devices.This report addresses the first device.

Manufacturer Narrative

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.The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of catheters separating from the connectors was confirmed and the cause appeared to be potentially related to product manufacture.The product returned for evaluation was two 4fr s/l groshong nxt two-piece connectors.Also received were two segments of 4fr s/l groshong catheter.Both connectors were received assembled.No segments or fragments of catheter were visible within the connectors.Microscopic inspection of the connectors did not reveal any mechanical damage or evidence of manipulation with instruments.The two connectors were disassembled and confirmed to contain no segments of catheter.The distal connector segments were longitudinally bisected.Inspection of the compression sleeves confirmed that they had been advanced into the locked position.Following longitudinal bisection of the distal connector segments, inspection of the bores revealed them to be irregularly shaped.The bores appeared irregular and began to narrow before the intended region.The bore inside diameters were measured using a digital microscope and found to be below the minimum distance defined in the product specifications.The lack of catheter segments within the assembled connectors indicated that the catheters were not inserted through the compression sleeves prior to assembly of the connectors.The too narrow connector bores may have interfered with insertion of the catheters during catheter/connector assembly.Photographs have been forwarded to the manufacturing site for further evaluation.

Event Description

It was reported that the oversleeve portion and the extension tubing were disengaged on the next day after completion of catheter maintenance, leading to the detachment of the catheter into the vessel of the patient.Additional information received: customer reports the distal catheter migrated into the patient's vessel and the proximal end is no longer coming out of the insertion site.There are no plans to retrieve the migrated catheter segment.Customer reports the "patient status is ok".A new catheter has not been placed.It was reported this occurred with two devices.This report addresses the first device.

• Brand Name: REPLACEMENT CONNECTOR FOR 4F GROSHONG NXT CLEARVUE PICC W/ EXTENSION LEG
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15825671
• MDR Text Key: 303920638
• Report Number: 3006260740-2022-05374
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741075261
• UDI-Public: (01)00801741075261
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 7812400
• Device Lot Number: REFN1918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 12/20/2022; 03/13/2023
• Supplement Dates FDA Received: 12/22/2022; 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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
• Patient Outcome(s): Required Intervention