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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 damaged infusion set is confirmed; however, the exact cause is unknown.One photograph of a 22 g miniloc winged infusion set was returned for evaluation.An initial visual observation of the photograph showed use residue throughout the sample, and a large diagonal split with straight and distinct edges was observed in the tubing near the needle housing of the infusion set in the returned photograph.While the angle and distinct edges of the split in the tubing of the infusion suggest the device was likely damaged by a sharp instrument, this could not be confirmed from the returned photograph; therefore, the exact cause of the damage is unknown at this time.A lot history review (lhr) of asduf027 showed three other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same patient.
Event or Problem Description
It was reported patient reports miniloc tubing pulled out of needle.No other information was provided.

• Brand Name: MINILOC SAFETY INFUSION SET 22G 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: 10258485
• Report Number: 3006260740-2020-02372
• Device Sequence Number: 3065445
• Product Code: FPA
• UDI-Device Identifier: 00801741047602
• UDI-Public: (01)00801741047602
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2020

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: 0632234
• Device Lot Number: ASDUF027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 07/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1