MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASIC TRAY; CATHETER, PERCUTANEOUS

Model Number N/A

Device Problem Defective Component (2292)

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

Event Date 11/17/2023

Event Type  malfunction  

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 received.

Event Description

It was reported on (b)(6) 2023, the patient was admitted to our department with cerebral artery occlusion and cerebral infarction for 4.5 hours due to left limb weakness and speech impairment, and on (b)(4), when the picc catheter was indwelled, it was found that the central venous catheter through the peripheral cannula was not smooth and could not be used.No other information was provided.

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 complaint of a damaged catheter is unconfirmed because the problem could not be found nor reproduced.The product returned for evaluation was a groshong catheter with inlaid stylet, introducer needle, and catheter.Light residue was observed on catheter.An attempt to flush the catheter with water using a 12ml syringe revealed the catheter was patent to infusion and aspiration with no observed leaks.Microscopic inspection of the catheter, introducer needle, and iv catheter was unremarkable.The complaint of a damaged catheter could not be found nor reproduced; therefore, this complaint is unconfirmed at this time.This complaint will be recorded for future trending and monitoring purposes.

Event Description

It was reported on (b)(6) 2023, the patient was admitted to our department with cerebral artery occlusion and cerebral infarction for 4.5 hours due to left limb weakness and speech impairment, and on november 17, when the picc catheter was indwelled, it was found that the central venous catheter through the peripheral cannula was not smooth and could not be used.No other information was provided.

• Brand Name: GROSHONG 4F SL PICC PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER BASIC TRAY
• Type of Device: CATHETER, PERCUTANEOUS
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18332229
• MDR Text Key: 330962190
• Report Number: 3006260740-2023-05718
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K871080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• 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: 7715405
• Device Lot Number: REFU3908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2021
• 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): Other