MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 1 IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	LH-0030YN
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of ascus0219 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that no needle cover.It was stated the rn take other needle cover to it.No other information was 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 a clear liquid within the tubing of the infusion set.Both pinch clamps on the extension tubing were observed to be engaged, and no dust cap was returned on or with the sample.A needle cover was returned on the needle of the returned sample; however, the complainant specified this needle cover was from another sample.The opened state of the packaging made it difficult to assess when and where the needle guard allegedly became detached and/or went missing.Possible causes include improper kit assembly and misplacement of the component after opening.A lot history review (lhr) of ascus0219 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that no needle cover.It was stated the rn take other needle cover to it.No other information was provided.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 1 IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10214480
• Report Number: 3006260740-2020-02281
• Device Sequence Number: 2108393
• Product Code: FPA
• UDI-Device Identifier: 00801741066191
• UDI-Public: (01)00801741066191
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K153440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Expiration Date: 06/28/2021
• Device Model Number: LH-0030YN
• Device Catalogue Number: LH-0030YN
• Device Lot Number: ASCUS0219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1