MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG SINGLE LUMEN CATHETERS; CHRONIC CATHETERS

Model Number	7711700
Medical Device Problem Codes	Fracture (1260); Air/Gas in Device (4062)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	05/12/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that five months and eight days post the chronic catheter placement, an alleged crack was observed on the catheter valve connector causing air embolism.It was further reported the patient expired.Reportedly, the patient was being treated for severe pulmonary arterial hypertension and epoprostenol was being administered.Patient's cause of death is unknown.
Additional Manufacturer Narrative
H10: date of death for this patient was not provided, date of death updated as (b)(6) 1900 for the mdr submission requirement.H10: as the lot number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4 (expiry date: 05/2026).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 or Problem Description
It was reported that sometime post a chronic catheter placement, an alleged crack was observed on the catheter valve connector causing air embolism.It was further reported the patient expired.Reportedly, the patient was being treated for severe pulmonary arterial hypertension and epoprostenol was being administered.Patient's cause of death is unknown.
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.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failures of catheter connector crack and attendant air embolism as no objective evidence was provided for review.Note that the connector was described as a "groshong valve connector." to clarify, the connector itself does not have a valve, but the tip of the catheter does.Also, the relationship between the reported catheter connector crack/air embolism and the patient death has not been established.The definitive root cause could not be determined based upon the available information.Labeling review: as the reported event did not allege a labeling or use related issue, therefore a labeling review is not required.H10: d4 (expiration date: 05/2026), g3, h6 (method) 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: GROSHONG SINGLE LUMEN CATHETERS
• 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 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: 17084562
• Report Number: 3006260740-2023-02343
• Device Sequence Number: 5907232
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2023

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
• Operator of Device: Health Professional
• Device Model Number: 7711700
• Device Catalogue Number: 7711700
• Device Lot Number: REFT0922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 12/02/2023
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Patient Weight: 55 KG