MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP 22G X3/4 SAFETY INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

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 during removal of safestep from the port body, the base did not move down and the safety mechanism did not work.There was no reported patient injury.

Event Description

It was reported that during removal of safestep from the port body, the base did not move down and the safety mechanism did not work.There was no reported patient injury.

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, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged safety mechanism is confirmed and appears to be caused by a bend in the needle shaft.One 22 ga x 0.75 in safestep infusion set was returned without product packaging.The safety mechanism was not advanced.Evidence of use was present within the extension tubing.A slight bend was observed.An attempt to advance the safety mechanism revealed excessive resistance.Additional force was applied in order to successfully activate the safety mechanism.A noticeable bend in the needle shaft was observed near the proximal end of the needle.Microscopic observation revealed no significant needle bevel deformation.The bend in the needle shaft was likely caused by force applied during insertion or use of the device.Since the bend was the source of the difficult safety mechanism activation, the complaint is confirmed and appears to be related to the use of the device.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: SAFESTEP 22G X3/4 SAFETY INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9849122
• MDR Text Key: 194332723
• Report Number: 3006260740-2020-00881
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066160
• UDI-Public: (01)00801741066160
• Combination Product (y/n): N
• PMA/PMN Number: K040527
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1