MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP PORT ACCESS KIT 22G X 0.75IN; HYPODERMIC SINGLE LUMEN NEEDLE.

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of reep1004 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported port needle inserted into port in left chest of patient and was noted to have leaking at the needle connection on the device.
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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.
Event or Problem Description
It was reported port needle inserted into port in left chest of patient and was noted to have leaking at the needle connection on the device.(b)(6) 2020 - returned sample has no damage or defects and doesn't leak.

• Brand Name: SAFESTEP PORT ACCESS KIT 22G 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: 10215404
• Report Number: 3006260740-2020-02288
• Device Sequence Number: 11289768
• Product Code: FPA
• UDI-Device Identifier: 00801741085482
• UDI-Public: (01)00801741085482
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• 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: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: PA-0029
• Device Lot Number: REEP1004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 07/07/2020
• Initial Report FDA Received Date: 06/30/2020
• 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