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

Model Number N/A

Device Problems Difficult to Flush (1251); Failure to Infuse (2340)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported by a customer "she is having difficulty flushing the white port of her double lumen groshong cvc.Caller states the red lumen is flushing ok but not great.Caller states she had this catheter placed on (b)(6)2023.Caller states her doctor advised her to flush the catheter with a 3ml syringe.Caller states the doctor did not add the product code or lot # to her medical records." informed caller she need to contact her implanting doctor to evaluate the catheter.Advised per the ifu, "do not use a syringe smaller than 10 ml" additional information from customer: after speaking with her she stated that there was no issue with the vad.The surgeon had made a stich around the catheter line to tight.After the surgeon removed the stich it flowed perfectly fine.

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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned.

Manufacturer Narrative

H10: as the lot number for the device was not provided, a review of the device history records could not 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.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.H3 other text : device not returned.

Event Description

It was reported that sometime post chronic catheter placement, the catheter allegedly had difficulty in flushing.It was further reported that the red lumen had flushed okay but not great.Furthermore, the surgeon had made a stitch around the catheter line too tight.Reportedly, after the surgeon removed the stitch, it flowed perfectly fine.There was no reported patient injury.

• Brand Name: GROSHONG DUAL 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: 17339370
• MDR Text Key: 319373156
• Report Number: 3006260740-2023-03016
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNK GROSHONG D/L CATHETERS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 08/12/2023
• Supplement Dates FDA Received: 09/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Sex: Female