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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/24/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12181021
• Report Number: 3006260740-2021-02772
• Device Sequence Number: 2825973
• Product Code: FPA
• UDI-Device Identifier: 00801741118272
• UDI-Public: (01)00801741118272
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: AS142075
• Device Lot Number: REEX2518
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR