MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EZ HUBER 20G X 25MM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported ¿needle shows severe bending." no other information was provided.01/20/2023 - the returned sample exhibited a bend.The safety could not be advanced over the bent region of the needle.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a bent infusion set needle was confirmed and the cause was determined to be use related.The product returned for evaluation was a one 20ga x 1" powerloc ez safety infusion set.The returned product sample was evaluated and the needle was observed to be bent near the exit site from the non-engaged safety mechanism the following observations were noted during the sample evaluation: usage residue was seen on the sample which proved that the product had experienced at least some use.The needle tip was barbed suggesting contact between the needle and port base.An attempt to advance the safety over the needle tip was unsuccessful as the safety could not pass the bent region of the needle.Force applied at an angle to the needle axis or if the needle is not inserted perpendicular into the port septum can lead to bending of the needle shaft.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle; if too long, needle and/or port may be damaged at insertion.Additionally, avoid excessive manipulation once the needle is in the port.No potential damage related to the manufacturing process was noted on the complaint sample.A batch history review (bhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: EZ HUBER 20G X 25MM
• Common Device Name: 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16247373
• Report Number: 3006260740-2023-00134
• Device Sequence Number: 17718808
• Product Code: FPA
• UDI-Device Identifier: 00801741089169
• UDI-Public: (01)00801741089169
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K071846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2023

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: SHG20-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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