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

Model Number 7711700

Device Problems Fluid/Blood Leak (1250); Suction Problem (2170); Air/Gas in Device (4062)

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

Event Date 05/23/2022

Event Type  malfunction  

Event Description

It was reported that four days post chronic catheter placement, the catheter allegedly leaking liquid from the external part of the catheter.It was further reported that catheter allegedly had no blood return and air was allegedly present in the tubing of the device.Reportedly, the catheter was removed.There was no reported patient injury.

Manufacturer Narrative

Date of event was entered as date of explant due to system limitations, since date of event was unknown.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.(expiry date: 02/2026).

Manufacturer Narrative

H10: date of event was entered as date of explant due to system limitations, since date of event was unknown.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 sample was not returned for evaluation, two electronic photos were provided for review.The investigation is inconclusive for the reported issues, as no leaks were noted on the provided photos.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.H10: d4 (expiry date: 02/2026).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.H3 other text : device not returned.

Event Description

It was reported that approximately two days post chronic catheter placement, the catheter allegedly leaking liquid from the external part of the catheter.It was further reported that that catheter allegedly had no blood return and air was allegedly present in the tubing of the device.Reportedly, the catheter was removed.There was no reported patient injury.

• Brand Name: GROSHONG SINGLE LUMEN CATHETERS
• Type of Device: 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: 14741844
• MDR Text Key: 296853935
• Report Number: 3006260740-2022-02344
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K831386
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7711700
• Device Catalogue Number: 7711700
• Device Lot Number: REFQ2510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2021
• 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