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
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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.
Additional 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 or Problem 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)(6) 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
• Common Device Name: 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
• Report Number: 3006260740-2023-05718
• Device Sequence Number: 6740206
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296(17)240630(10)REFU3908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K871080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/21/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2023
• Supplement Date Received by Manufacturer: 04/08/2024; 06/12/2024; 06/12/2024
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 04/12/2024; 06/18/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: Other
• Patient Sex: Unknown