MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/19/2023

Event Type  Death  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of regp2541 showed no other similar product complaint(s) from this batch number.

Event Description

It was reported that during post mortem the remains of a picc were found in the persons atrium.Picc inserted (b)(6) 2022, x ray on admission to hospital on (b)(6) 2022 reported that the device was in a correct position.The picc was removed at sometime after this on patients admission to hospital but there is no documentation as to when this happened.The patient was undergoing chemotherapy and it is unknown at this time as to the cause of death, and the findings of the remains of the picc was only after the patients death on postmortem.Additional information received on 2/2/2023: customer reports that the catheter fragments found during post-mortem care are believed to be from the picc.The cause of death is being investigated by the coroner and is currently unascertained.The patient expired (b)(6) 2022.

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.

Event Description

It was reported that during post mortem the remains of a picc were found in the persons atrium.Picc inserted (b)(6) 2022, x ray on admission to hospital on (b)(6) 2022 reported that the device was in a correct position.The picc was removed at sometime after this on patients admission to hospital but there is no documentation as to when this happened.The patient was undergoing chemotherapy and it is unknown at this time as to the cause of death, and the findings of the remains of the picc was only after the patients death on postmortem.Additional information received on 2/2/2023: customer reports that the catheter fragments found during post-mortem care are believed to be from the picc.The cause of death is being investigated by the coroner and is currently unascertained.The patient expired (b)(6) 2022.Additional information received: device being used for parenteral nutrition.Inserted in the right basilic vein.Lidocaine used at insertion site.

• Brand Name: GROSHONG NXT CLEARVUE CATHETER WITH SHERLOCK 3CG TIP
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16385837
• MDR Text Key: 309664877
• Report Number: 3006260740-2023-00461
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: 801(E)
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2023

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 Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: CK000516
• Device Lot Number: REGP2541
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2023
• Initial Date FDA Received: 02/16/2023
• Supplement Dates Manufacturer Received: 03/20/2023
• Supplement Dates FDA Received: 03/24/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2022
• 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): Death
• Patient Age: 68 YR