MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC PORT ACCESS KIT 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported by healthcare professional "we had a miniloc port access kit from bard used on thursday last week and one side of the "y" was not actually connected." no other information was provided.
Event or Problem Description
It was reported by healthcare professional "we had a miniloc port access kit from bard used on thursday last week and one side of the "y" was not actually connected." no other information was provided.
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, applicable previous investigation(s), sample analysis, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached extension tube was confirmed and the cause appeared to be supplier-related.The product returned for evaluation was one 20ga x 0.75¿ miniloc safety infusion set with y-site.Light usage residues were observed and the safety mechanism was engaged.Needleless injection caps were attached to both luer adapters.The proximal extension tubing was completely detached from the y-site.Microscopic inspection of the distal end of the proximal extension tubing revealed a glossy striated surface typical of a sharp instrument cut.Inspection of the y-site revealed no tubing fragment.Tactile inspection of the sample did not reveal any tensile weakness.Inspection of the extension tubing and y-site using an ultraviolet light revealed a small amount of adhesive residue on the distal end of the tubing.No adhesive residue was observed within the y-site orifice.The observed detachment appeared to be the result of insufficient adhesive at the tubing/y-site joint.It appeared that inadequate adhesive was applied during the assembly process.The device is a supplied component and the supplier has been notified of this event.A batch history review (bhr) of (b)(4).Showed no other similar product complaint(s) from this batch number h3 other text : evaluation findings are in section h.11.

• Brand Name: MINILOC PORT ACCESS KIT 20G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer Contact: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15136078
• Report Number: 3006260740-2022-02965
• Device Sequence Number: 5268477
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2023

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: 2682034
• Device Lot Number: REGP2422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2022
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 07/29/2022
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown