MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HUBER PLUS 22G X 0.75"; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Material Deformation (2976); Activation Problem (4042)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that during removal, the safety mechanism could not be activated.
Additional Manufacturer Narrative
H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty activating the safety mechanism was confirmed.The product returned for evaluation was a one 22ga x 0.75" huber plus safety infusion set.The returned product sample was evaluated and the needle was observed to be bent at the exit site from the needle housing.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 the sample was received with the safety partially engaged.The safety was easily fully engaged during preliminary evaluation; however, the needle damage suggested that needle deformation may have complicated safety activation during device removal from the port.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 lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported that during removal, the safety mechanism could not be activated.

• Brand Name: HUBER PLUS 22G X 0.75"
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10583811
• Report Number: 3006260740-2020-03364
• Device Sequence Number: 14158758
• Product Code: FPA
• UDI-Device Identifier: 00801741065712
• UDI-Public: (01)00801741065712
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K993848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2020

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: 012234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1