MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ALLPOINTS PORT ACCESS SYSTEM 20 G X 0.75 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Unspecified Infection (1930)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reex2518 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reex2518) have been reported from the same facility.Device not returned for evaluation.

Event Description

It was reported "we have a (b)(6) year old that now has had 2 tubing fractures with the power needle in the all points kits and unfortunately he has a confirmed clabsi.Rl¿s have been placed and one of the needles was sent to value analysis." this report addresses the device that was not sent to value analysis.

• Brand Name: ALLPOINTS PORT ACCESS SYSTEM 20 G X 0.75 IN
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12181021
• MDR Text Key: 261949723
• Report Number: 3006260740-2021-02772
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741118272
• UDI-Public: (01)00801741118272
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171735
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AS142075
• Device Lot Number: REEX2518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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): Required Intervention
• Patient Age: 3 YR