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

Model Number N/A

Device Problems Misassembled (1398); Activation Problem (4042)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, 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 a detached safety mechanism is confirmed and was determined to be supplier related.One photograph of a 22g safestep infusion set was returned for evaluation.An initial visual observation of the photograph showed the safety mechanism of the infusion set completely detached from the needle shaft.This detachment of the safety mechanism was most-likely caused by a missing metal sleeve within the safety mechanism, which likely occurred due to misassembly of the device during manufacture at the supplier facility.A lot history review (lhr) of asdvs0125 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when removing lh0029, the handle is separated from the safety plate.No other information was provided.

Event Description

It was reported that when removing lh0029, the handle is separated from the safety plate.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 a detached safety mechanism was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 22ga x 0.75¿ safestep safety infusion set.Use residues were observed throughout the sample.The safety plate was received completely detached from the infusion set assembly.Microscopic inspection of the safety mechanism revealed that it had been assembled correctly.The needle shaft od and metal sleeve id were measured and found to be within manufacturing specifications.Needle tip and metal sleeve deformation were observed.Longitudinal scoring marks were observed along the needle shaft.All of the interfacing components were found to be within manufacturing specifications.The use residue, deformation and longitudinal scoring marks suggested that the safety mechanism detachment was likely caused by forceful safety activation during device removal.A lot history review (lhr) of asdvs0125 showed no other similar product complaint(s) from this lot number.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G 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: 10117133
• MDR Text Key: 195951249
• Report Number: 3006260740-2020-01936
• 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
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2022
• Device Model Number: N/A
• Device Catalogue Number: LH-0029
• Device Lot Number: ASDVS0125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1