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

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of asdxs0087 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that it was found that there was no needle cover upon opening the package.It was further reported that another safestep was used to complete the procedure.There was no reported patient contact.

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 review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing needle guard is inconclusive due to the state of the returned sample.One 22 g x 0.75 in.Safestep infusion set was returned for evaluation.An initial visual observation showed the sample was returned in an open package.A needle guard and end cap were observed on the returned sample.Because the sample was returned in an open package and was returned with a needle guard on the needle of the device, it was not possible to confirm the alleged issue or determine a root cause.A lot history review (lhr) of asdxs0087 showed one other similar product complaint(s) from this lot number.

Event Description

It was reported that it was found that there was no needle cover upon opening the package.It was further reported that another safestep was used to complete the procedure.There was no reported patient contact.

• 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: 10620550
• MDR Text Key: 209955872
• Report Number: 3006260740-2020-03427
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066177
• UDI-Public: (01)00801741066177
• Combination Product (y/n): N
• PMA/PMN Number: K153440
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: N/A
• Device Catalogue Number: LH-0029
• Device Lot Number: ASDXS0087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Event Location: Hospital
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1