MAUDE Adverse Event Report: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Material Twisted/Bent (2981); Activation Problem (4042)

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

Event Date 04/28/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asewf038 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that during removal, the safety mechanism could not be activated.User remove the device directly.No other information was provided.

Event Description

It was reported that during removal, the safety mechanism could not be activated.User remove the device directly.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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty activating a safety mechanism is confirmed; however, the exact cause is unknown.One 22 g x 0.75 in.Safestep infusion set was returned for evaluation.An initial visual observation showed use residue on the returned sample.The safety mechanism was observed to not be activated, and the needle was observed to be bent near its base.A microscopic observation revealed a yellow-brown residue on the needle shaft and the metal sleeve of the safety mechanism.This residue was found to fluoresce under uv light; however, it in unknown of this residue was present prior to use or if the sample came into contact with it during use.No damage was observed on the needle tip.Resistance was met when attempting to activate the safety mechanism; however, the safety mechanism was able to be fully engaged over the needle tip with some force.The bend in the needle was found to be severe enough and in a location where it would cause difficulties in activating the safety mechanism of the returned infusion set.Additionally, the observed residue on the needle shaft may have also contributed to this difficulty in activation.However, it is unknown when or where the returned sample was bent or may have come into contact with the observed residue.Therefore, the root cause(s) of the difficulty encountered while attempting to activate the safety mechanism is unknown.Possible causes include damage during storage, handling, or use.H3 other text: evaluation findings are in section h11.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12397295
• MDR Text Key: 269327171
• Report Number: 3006260740-2021-03628
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0029
• Device Lot Number: ASEWF038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Initial Date Manufacturer Received: 08/10/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 09/17/2021
• Supplement Dates FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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