MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 PICC, REPAIR KITS

Catalog Number	7812400
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2025
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 manufacturer has received the sample and it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer that on june 15, 2025, nurses rounding the ward, found that the patient micro pump was alarming.Nurses checked the appearance of the patient's peripherally cannulated central venous catheter without damage.The nurse checked the return of flushing fluid back to the pump without return blood but also cannot be pushed forward.The nurse then replaced the peripherally cannulated central venous catheter accessories, back to the pump there is return blood, peripheral cannulation of central venous catheter fluent.The incident did not cause harm to the patient.No further information was provided.
Additional Manufacturer Narrative
Initial medwatch report was submitted, upon further review it was found that this medwatch report is a duplicate file and has been voided.The original event was submitted on medwatch report 3006260740-2025-04989.

• Brand Name: PICC, REPAIR KITS
• Common Device Name: PICC, REPAIR KITS
• 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: veronica lee ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22513096
• Report Number: 3006260740-2025-04840
• Device Sequence Number: 8736376
• Product Code: LJS
• UDI-Device Identifier: 00801741075261
• UDI-Public: (01)00801741075261(11)240427(17)290228(10)REJQ1275
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K034020
• 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): 08/14/2025

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: 7812400
• Device Lot Number: REJQ1275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/27/2024
• 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