MAUDE Adverse Event Report: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Material Deformation (2976); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/21/2021

Event Type  malfunction  

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 Description

It was reported by healthcare professional "when writer de-accessed patient's ivad, it was difficult to remove.Safety feature not able to be used as needle was found to be very bent upon removal."no other information was provided.

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 a bent infusion set needle was confirmed.The product returned for evaluation was a one 22ga x 0.75" safestep safety infusion set.The returned product sample was evaluated and the needle was observed to be bent at the exit site from the non-engaged safety and approximately midway along the needle shaft.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 bend in the needle had occurred away from the needle base which can be caused by device manipulation during/following port access the needle tip was barbed suggesting contact between the needle and port base.A functional test of the safety mechanism found that the safety mechanism would not engage over the needle tip due to the bend within 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.H3 other text : sample evaluation findings in manufacturer's notes.

Event Description

It was reported "when writer de-accessed patient's ivad, it was difficult to remove.Safety feature not able to be used as needle was found to be very bent upon removal.".

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12631567
• MDR Text Key: 276387520
• Report Number: 3006260740-2021-04382
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0029
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2021
• Date Manufacturer Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other