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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of asftf116 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer "patient presented to clinic with needle intact/port accessed.Dressing intact, able to flush port, blood return obtained.While at home, patient stated that he noticed that the iv tubing had become completely dislodged from the primary hub connection site on the infusion set.".
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, complaint and batch history, applicable previous investigation(s), photo analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached hub on the infusion set was confirmed but the cause is unknown.A photograph of the implicated 20g miniloc safety infusion set was returned for evaluation.The infusion set contained characteristics of use (e.G., residual material within the tubing and y-site, an activated safety mechanism, and auxiliary devices attached to the infusion set).The side tail luer adaptor had completely detached from the tubing.It could not be determined from the photograph if the tubing had broken near the joint or if the tubing had dislodged from the luer adaptor.The observable features on the submitted photograph did not contain enough information to identify a specific root cause of the reported event.Possible contributing factors could include tensile (pulling) damage, material fatigue, or damage from a sharp instrument.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by the customer "patient presented to clinic with needle intact/port accessed.Dressing intact, able to flush port, blood return obtained.While at home, patient stated that he noticed that the iv tubing had become completely dislodged from the primary hub connection site on the infusion set." additional information received: the tubing was ¿tied¿ off by patient when he realized the tubing became completely dislodged.Date of occurrence: (b)(6) 2022.Placement date: (b)(6) 2022 explant date: (b)(6) 2022 was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.No harm; however, the potential for harm was 100%.

• Brand Name: MINILOC SAFETY INFUSION SET 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15033873
• Report Number: 3006260740-2022-02743
• Device Sequence Number: 20568749
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2022

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: 0682034
• Device Lot Number: ASFTF116
• 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: 06/27/2022
• Supplement Date Received by Manufacturer: 08/10/2022
• Initial Report FDA Received Date: 07/15/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2021
• 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 Age: 76 YR
• Patient Sex: Male