MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 22G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and was determined to be use related.One 22 g x 0.75 in.Miniloc winged infusion set with a y-site was returned for evaluation.An initial visual observation showed a large split in the tubing of the infusion set, approximately 1 cm distal to the proximal luer hub.Tensile weakness was observed in the tubing around the split.A hard, clear substance was observed in the proximal section of tubing and this substance was found to occlude the tubing when an attempt was made to flush the sample.A microscopic observation revealed the edges of the split were straight and smooth and the fracture surface was observed to be granular in texture.The edges of the split were also observed to be slightly wavy, most-likely due to hyperextension of the material prior to the burst.The damage observed in the returned sample was characteristic of over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10 ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The product ifu states: ¿high pressure or use with power injectors may cause leakage or damage.¿ a lot history review (lhr) of ascqs0122 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the miniloc tubing "exploded" during injection.Complainant stated that "it doesn't sound like any harm came from the leak".

• Brand Name: MINILOC SAFETY INFUSION SET 22G 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: 8692963
• Report Number: 3006260740-2019-01630
• Device Sequence Number: 1875719
• Product Code: FPA
• UDI-Device Identifier: 00801741048081
• UDI-Public: (01)00801741048081
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2019

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: 0682234
• Device Lot Number: ASCQS0122
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 06/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1