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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged infusion set tubing is confirmed and appears to be use related.One 20 ga x 0.75 in miniloc infusion set was provided for investigation.The device was returned in two segments with a complete split in the extension tubing.The proximal section of the extension tubing extended 5 mm from the distal end of the luer adaptor.Microscopic observation of the split surfaces revealed them to be smooth.The surface texture appeared to be striated consistent with damage caused by a sharp instrument.The split edges appeared to form a v shape peak which suggest a two-bladed instrument, such as scissors, may have come into contact with the extension tubing.Additional surface damage on the extension tubing was observed on the distal segment.The damage was angled and left an indentation on the material.No additional damage to the tubing was observed on the proximal and distal section of the extension tubing.The distal segment of the extension tubing was flushed with water using a 12 ml syringe and connector adapter.No apparent leaks in the tubing or needle housing were observed.Based on the characteristics of the split surface, it is likely that the extension tubing was damage by a ground sharpened instrument; therefore, the complaint is confirmed and appears to be related to the use of the device.A lot history review (lhr) of ascys0137 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the needle was broke.On (b)(6) 2020 - the returned needle has a broken extension set and also had residue inside that did not appear to be saline crystals but may have been infusate crystals.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 0.75IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10006165
• Report Number: 3006260740-2020-01526
• Device Sequence Number: 11448276
• Product Code: FPA
• UDI-Device Identifier: 00801741048784
• UDI-Public: (01)00801741048784
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2020

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 Model Number: N/A
• Device Catalogue Number: S02020-75
• Device Lot Number: ASCYS0137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1