MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ALLPOINTS PORT ACCESS SYSTEM POWERLOC MAX; NON-CORING (HUBER) NEEDLE

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "customer said that when she was using one of the powerloc max needles from the new kits they had an issue.She stated that there was a hole in the tubing coming from the y-site that was leaking.".
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refn4046 showed no other similar product complaint(s) from this lot number.

• Brand Name: ALLPOINTS PORT ACCESS SYSTEM POWERLOC MAX
• Common Device Name: NON-CORING (HUBER) NEEDLE
• 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: 12790860
• Report Number: 3006260740-2021-04774
• Device Sequence Number: 14457576
• Product Code: PTI
• UDI-Device Identifier: 00801741215216
• UDI-Public: (01)00801741215216
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/26/2021

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 Model Number: N/A
• Device Catalogue Number: AN132075B
• Device Lot Number: REFN4046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/21/2021
• Initial Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2021
• 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