MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problems Nonstandard Device (1420); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

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 detachment was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which depicted a 20ga safestep safety infusion set.The device was contained in a plastic bag.A syringe was attached to the luer adapter.Usage residues appeared to be present within the device.The safety mechanism plate appeared to be detached from the needle.While it appeared that the safety mechanism plate was detached from the infusion set in the supplied photograph, inspection of that photograph was insufficient to identify the cause of the detachment.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include safety plate damage, needle damage and forceful advancement of the safety during needle withdrawal.A lot history review (lhr) of asdps0235 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when trying to active safety mechanism, needle separated with hub.

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 detachment was confirmed and the cause was supplier related.The product returned for evaluation was one 20ga x 1¿ safestep safety infusion set.The sample was received with the safety plate completely detached.The safety mechanism metal sleeve inner diameter was measured using a digital microscope.The inner diameter was found to be outside of manufacturing specifications.It appeared that the incorrect metal sleeve used during device assembly.This is a supplied component and the supplier has been notified of this event.A lot history review (lhr) of asdps0177 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when trying to active safety mechanism, needle separated with hub.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9056691
• MDR Text Key: 158635709
• Report Number: 3006260740-2019-02716
• 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: 10/15/2019

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-0032
• Device Lot Number: ASDPS0177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/22/2019
• Initial Date FDA Received: 09/14/2019
• Supplement Dates Manufacturer Received: 09/30/2019
• Supplement Dates FDA Received: 10/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1