MAUDE Adverse Event Report: SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asdps0165 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that when opening the package, it was noticed that the cover of needle was not contained in it.There was no reported patient involvement.No other information provided.
Additional 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 cover is inconclusive due to the state of the returned sample.One 22 g x 1 in.Safestep infusion set with a valved y-site was returned for evaluation.An initial visual observation showed no obvious evidence of use on the returned sample.A cap was returned on the proximal luer hub, but no needle guard was returned on or with the returned sample.While no needle guard was returned on or with the returned sample, the sample was returned outside of any packaging which made it difficult to determine when and where the component may have gone missing.
Event or Problem Description
It was reported that when opening the package, it was noticed that the cover of needle was not contained in it.There was no reported patient involvement.No other information provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 1 IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12100117
• Report Number: 3006260740-2021-02528
• Device Sequence Number: 3652223
• Product Code: FPA
• UDI-Device Identifier: 00801741066191
• UDI-Public: (01)00801741066191
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2021

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0030YN
• Device Lot Number: ASDPS0165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 08/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other