MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP PORT ACCESS KIT 20G X 0.75IN; HYPODERMIC SINGLE LUMEN NEEDLE.

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 recs1135 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
The device exhibited a detached needle housing.
Event or Problem Description
The device exhibited a detached needle housing.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a detached needle housing is confirmed and was determined to be supplier related.One 20 g x 0.75 in.Safestep infusion set was returned for evaluation.An initial visual observation showed the needle housing was detached from the tubing of the infusion set.Use residue was observed on the returned sample, and the safety mechanism was observed to be fully activated.A microscopic observation revealed adhesive, striations, and a polished surface on the distal end of the tubing of the infusion set, indicating it is the manufactured end.Adhesive was observed within the distal end of the tubing as well as within about three quarters of the circumference of the proximal end of the needle housing.This device is a supplied component and the supplier has been notified.

• Brand Name: SAFESTEP PORT ACCESS KIT 20G X 0.75IN
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE.
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8047658
• Report Number: 3006260740-2018-03176
• Device Sequence Number: 11144570
• Product Code: FPA
• UDI-Device Identifier: 00801741085529
• UDI-Public: (01)00801741085529
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2018

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: PA-0031
• Device Lot Number: RECS1135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 10/18/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 11/07/2018
• Supplement Report FDA Received Date: 11/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1