MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SAFESTEP PORT ACCESS KIT 22G X 0.75IN WITH Y-SITE; 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)
Date of Event	07/27/2020
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 reen2778 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported two bard port access kits were found leaking at the clave and had to re-access a patient.This report addresses the second device.
Event or Problem Description
It was reported two bard port access kits were found leaking at the clave and had to re-access a patient.This report addresses the second 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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of infusion set leakage at the claves was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 22ga x 0.75¿ miniloc safety infusion set with y-site.Light usage residues were observed and the safety mechanism was engaged.Non-vad needleless injection caps were attached to both luer adapters.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration; however, during pressurization, spraying leaks were observed emanating from the septa of both injection caps.Microscopic inspection of the injection caps revealed splits in both septa.The splits were of a size and shape consistent with hypodermic needle tips.It appeared that needles had been used to access both needleless injection caps, rather than male luer-lock devices.That access resulted in damage to the injection caps which caused them to leak during device access.A lot history review (lhr) of reen2778 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

• Brand Name: SAFESTEP PORT ACCESS KIT 22G X 0.75IN WITH Y-SITE
• 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: 10457517
• Report Number: 3006260740-2020-03043
• Device Sequence Number: 1217820
• Product Code: FPA
• UDI-Device Identifier: 00801741085499
• UDI-Public: (01)00801741085499
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K171735
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/23/2020

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: PA-0029YN
• Device Lot Number: REEN2778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 08/26/2020
• Supplement Report FDA Received Date: 11/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1