MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 BARD PORT ACCESS SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Fluid Leak (1250); Fracture (1260)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/06/2021

Event Type  Injury  

Event Description

It was reported that a patient felt unwell two hours after starting the infusion via pac. Blood sampling via port went well. After x-ray control under contrast, leakage was seen at the trunk of the gate. It was thought that the lock was loose when the gate was removed. This was found not to be the case but there was a crack in the transparent piece but not the lock. It was stated the patient has been given a new port.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation. A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: BARD PORT ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12759777
• MDR Text Key: 280480228
• Report Number: 3006260740-2021-04693
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/11/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/07/2021 Patient Sequence Number: 1