MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2019
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 asdvf003 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s customer reports oncology patient receiving chemotherapy was access in oncology with chemotherapy started and was then discharged to home to complete the 4-6 hour infusion when "after a while at home the tubing separated from the casing resulting in bleeding and chemotherapy in the home." customer states miniloc was covered with an occlusive dressing when patient was discharged to home.On (b)(6) 2019: no patient harm reported.
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 lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached hub is confirmed and the cause appears to be supplier related.The returned product was one 20 ga x 0.75 in miniloc infusion set.An initial visual observation showed the proximal hub to be detached from the extension tubing.Dried, red residue was present near the distal end of the extension tubing.A microscopic observation of the proximal end of the extension tubing did not reveal a break in the extension tubing.A ring of adhesive was present which indicates adhesive was applied during the manufacturing process.Additional adhesive was present within the distal end of the luer hub.Tactile evaluation of the proximal end of the extension tubing did not reveal any apparent material weakness to indicate exposure to excessive tensile forces.Due to the lack of evidence of exposure to excessive tensile force, possible contributing factors include insufficient adhesive and curing.The supplier has been notified of this event.A lot history review (lhr) of asdvf003 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported via ms&s customer reports oncology patient receiving chemotherapy was access in oncology with chemotherapy started and was then discharged to home to complete the 4-6 hour infusion when "after a while at home the tubing separated from the casing resulting in bleeding and chemotherapy in the home." customer states miniloc was covered with an occlusive dressing when patient was discharged to home.(b)(6)2019 : no patient harm reported.(b)(6)2020 : additional information rec'd via medwatch: "a pt in our oncology dept.Was receiving chemotherapy (5fu-fluorouracil).This was part of a 48 hour long infusion.The pt was receiving the course of his chemo at home.The access device-bard miniloc safety infusion set was used.The tubing separated from the hard plastic end (not broken, but slid out of the casing).As this was accessing a central line, the pt lost quite a bit of blood at home prior to being able to clamp off the access device.Furthermore, this resulted in a small quantity being wasted as the medication pump kept infusing.".

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN WITH Y-SITE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9513336
• Report Number: 3006260740-2019-03997
• Device Sequence Number: 2079643
• Product Code: FPA
• UDI-Device Identifier: 00801741048043
• UDI-Public: (01)00801741048043
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020
• Report Date (Section F): 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 0682034
• Device Lot Number: ASDVF003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/04/2019
• Event Location: Home
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/23/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 12/06/2019