MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 19G X 0.75IN WITH Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	0681934
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of aserf010 showed two other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported that there have been 3 patients with a baxter infusor (¿baby bottle¿) where the drug was not completely infused within the 46 hours administration time.They are worried that the port needles are becoming slightly dislodged and affecting the infusion rate.This report addresses the first device.
Event or Problem Description
It was reported that there have been 3 patients with a baxter infusor (¿baby bottle¿) where the drug was not completely infused within the 46 hours administration time.They are worried that the port needles are becoming slightly dislodged and affecting the infusion rate.This report addresses the first device.
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, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of infusion set dislodgement was inconclusive because the returned sample was not the originally implicated device.The product returned for evaluation was one 19ga x 0.75¿ miniloc safety infusion set with y-site.The sample was received in its original sealed packaging.A note was received with the sample indicating that it was an unused lot sample.Inspection of the sample was unremarkable.Microscopic inspection of the sample was unremarkable.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no leaks.The effort required to flush the sample was comparable to that required for a similar non-complainant device.While no deficiencies were discovered during evaluation of the returned sample, the sample was an unused lot sample.Consequently this complaint is inconclusive at this time.

• Brand Name: MINILOC SAFETY INFUSION SET 19G 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: 10522314
• Report Number: 3006260740-2020-03229
• Device Sequence Number: 11552246
• Product Code: FPA
• UDI-Device Identifier: 00801741048005
• UDI-Public: (01)00801741048005
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/14/2020

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 Expiration Date: 04/01/2023
• Device Catalogue Number: 0681934
• Device Lot Number: ASERF010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/15/2020
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 11/20/2020
• Initial Report FDA Received Date: 09/11/2020
• Supplement Report FDA Received Date: 12/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1