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

Model Number N/A

Device Problem Activation Problem (4042)

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

Event Date 04/01/2021

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 that device can not activate safety mechanism.No other information was provided.

Event Description

It was reported that device can not activate safety mechanism.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 safety mechanism failure was confirmed.The product returned for evaluation was one 22ga x 0.75¿ safestep safety infusion set.Usage residues were observed throughout the sample.The safety mechanism was not engaged.Residue was observed adhered between the sliding plates of the safety mechanism.An attempt to activate the safety mechanism revealed the safety to be mobile on the needle shaft.The safety failed to capture the needle tip because the plates did not move.Microscopic inspection of the safety confirmed the presence of residue between the sliding plates.The residue appeared to adhere the plates in place.The failure of the safety mechanism was caused by the safety plates not moving to cover the needle tip.The plates appeared to be adhered in place by use residue within the safety mechanism.Such deposition of residue can occur if infusion is attempted against resistance and if the port reservoir is not fully accessed during attempted infusion.H3 other text : evaluation findings are in section h.11.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12392014
• MDR Text Key: 268935450
• Report Number: 3006260740-2021-03613
• 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: 10/25/2021

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2021
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/31/2021
• Supplement Dates Manufacturer Received: 10/25/2021
• Supplement Dates FDA Received: 10/27/2021
• 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