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

Model Number N/A

Device Problems Material Deformation (2976); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2019

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 the safety mechanism not covering the needle tip was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a 20ga x 0.75¿ safestep safety infusion set.Usage residues were observed throughout the depicted device.A syringe was attached to the luer adapter.An injection cap was placed over the needle tip.The safety mechanism was advanced partially along the needle shaft but did not cover the needle tip.While it was apparent in the photograph that the safety mechanism was not covering the needle tip, inspection of the photograph was insufficient to determine the cause of the failure.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include safety mechanism damage and a bend in the needle shaft.A lot history review (lhr) of asdss0091 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that there was resistance felt during removal and the needle could not be retracted.No other information was provided.

Event Description

It was reported that there was resistance felt during removal and the needle could not be retracted.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 difficult safety activation was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 20ga x 0.75¿ safestep safety infusion set.Usage residues were observed throughout the sample.The safety mechanism was not engaged, but was partially advanced along the needle shaft.The needle shaft was bent.Microscopic inspection of the needle tip revealed it to be bent and flattened.The flattened region exhibited increased luster.An attempt to engage the safety mechanism was successful; however, resistance was encountered when passing the metal sleeve over the bent region of the needle.The resistance encountered when activating the safety mechanism was caused by the bent needle shaft.The usage residues and needle tip deformation suggested that bend likely occurred due to contact between the needle tip and the port reservoir base.It is advised to verify that the needle length is correct based on port reservoir depth, tissue thickness and the thickness of any dressing beneath the bend of the needle.A lot history review (lhr) of asdss0091 showed no other similar product complaint(s) from this lot number.

• 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: 9596529
• MDR Text Key: 190995259
• Report Number: 3006260740-2020-00126
• 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: 02/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• 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-0031
• Device Lot Number: ASDSS0091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Event Location: Hospital
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1