MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number N/A

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asdws0027 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asdws0027) have been reported from the same facility in (b)(4).

Event Description

It was reported after open the package, it was found no needle cover inside the package.

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 20 g x 0.75 in.Safestep infusion set with a valved y-site and what appears to be its original packaging were returned for evaluation.An initial visual observation showed no obvious evidence of use; however, some adhesive residue was observed on the distal tubing segment.The packaging was observed to be returned open, and a hole was observed in the center of the lid of the packaging.A white dust cap was returned on the luer hub of the sample; however, no needle guard was observed on the returned sample or within the returned packaging.A microscopic observation revealed no use residue on the returned sample.The needle tip was observed to be slightly damaged.The opened state of the packaging made it difficult to assess when and where the needle guard went missing.Possible causes include improper kit packaging and misplacement of kit components after opening.A lot history review (lhr) of asdws0027 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (asdws0027) have been reported from the same facility in taiwan.

Event Description

It was reported after open the package, it was found no needle cover inside the package.

• Brand Name: SAFESTEP HUBER NEEDLE SET 20G X 0.75IN WITH Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10028426
• MDR Text Key: 189994461
• Report Number: 3006260740-2020-01657
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00801741066214
• UDI-Public: (01)00801741066214
• 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: 06/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: LH-0031YN
• Device Lot Number: ASDWS0027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1