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

Model Number N/A

Device Problem Activation Problem (4042)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascws0132 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (ascws0132) have been reported from two facilities in (b)(6).

Event Description

It was reported the safety mechanism could not be activated.No other information was provided.

Event Description

It was reported the safety mechanism could not be activated.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, manufacturing review, applicable previous investigation(s) and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to activate the safety mechanism was unconfirmed as the safety mechanism was able to be activated during functional testing.One 20 ga x 0.75 in safestep infusion set was returned for investigation.Use residue was present throughout the device.The safety mechanism was not activated.No apparent bends in the needle shaft were observed.The safety mechanism was able to be fully advanced.Slight resistance was observed.Microscopic observation of the device revealed dried blood residue throughout the needle shaft and safety mechanism.Since the safety mechanism was able to be fully activated and the slight resistance appeared to be caused by the dried blood residue present on the device, the complaint is unconfirmed.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8741235
• MDR Text Key: 149631983
• Report Number: 3006260740-2019-01786
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066207
• UDI-Public: (01)00801741066207
• 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
• Type of Report: Initial,Followup
• Report Date: 07/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• 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-0031
• Device Lot Number: ASCWS0132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Event Location: Hospital
• Date Manufacturer Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1