MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 GROSHONG 4F SINGLE-LUMEN PICC BASIC TRAY; CATHETER, PERCUTANEOUS

Catalog Number	7715405
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	07/24/2024
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.
Event or Problem Description
It was reported that during the visit to reporting facility that on (b)(6)2024, more than three weeks after the sudden swelling of the arm, swelling area of 10 * 10cm, in accordance with the medical advice of picc extraction, found that the picc catheter into the body of the place of 1 ~ 2 centimeters of the place of the breakage, and foam dressing was immediately given to reduce swelling externally, and the swelling subsided without other adverse reactions after 3 days.As there was blood residue on the catheter, it was discarded as medical waste.No other information provided, at this time.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report 3006260740-2024-04772 is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2024-04630.
Event or Problem Description
It was reported that during the visit to reporting facility that on (b)(6) 2024, more than three weeks after the sudden swelling of the arm, swelling area of 10 x 10cm, in accordance with the medical advice of picc extraction, found that the picc catheter into the body of the place of 1 ~ 2 centimeters of the place of the breakage, and foam dressing was immediately given to reduce swelling externally, and the swelling subsided without other adverse reactions after 3 days.As there was blood residue on the catheter, it was discarded as medical waste.No other information provided, at this time.

• Brand Name: GROSHONG 4F SINGLE-LUMEN PICC 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20085896
• Report Number: 3006260740-2024-04772
• Device Sequence Number: 7847822
• Product Code: DQY
• UDI-Device Identifier: 00801741035296
• UDI-Public: (01)00801741035296
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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 Catalogue Number: 7715405
• Device Lot Number: REGX3240
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 08/28/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2022
• 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