MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.5IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/25/2020
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 asdvs0068 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that it was found that the needle cover was detached from the needle, so that the needle tip was uncovered upon opening the package.There was no reported patient contact.
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 detached needle guard is inconclusive due to the returned state of the sample.One 22 g x 0.5 in.Safestep infusion set in an open package was returned for evaluation.An initial visual observation showed no obvious evidence of use.A white dust cap was returned on the luer hub of the infusion set.No needle guard was returned.The needle was noted to be protruding from the packaging during the preliminary evaluation.A microscopic observation revealed a small hole in the clear plastic portion of the packaging of the infusion set.The needle tip was observed to be very slightly damaged.The opened state of the packaging made it difficult to assess when and where the needle guard became detached and/or went missing.Possible causes include improper kit packaging and misplacement of kit components after opening.A lot history review (lhr) of asdvs0068 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that it was found that the needle cover was detached from the needle, so that the needle tip was uncovered upon opening the package.There was no reported patient contact.

• Brand Name: SAFESTEP HUBER NEEDLE SET 22G X 0.5IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10176651
• Report Number: 3006260740-2020-02155
• Device Sequence Number: 2464054
• Product Code: FPA
• UDI-Device Identifier: 00801741066290
• UDI-Public: (01)00801741066290
• 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: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: 07/28/2022
• Device Model Number: N/A
• Device Catalogue Number: LH-0035
• Device Lot Number: ASDVS0068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/26/2020
• Supplement Date Received by Manufacturer: 07/02/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1