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	Activation Problem (4042)
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
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 were two needle stick injuries.It was stated when the needle is pulled and secured back into the safety lock, sometimes the tip will not completely retract into the device (even though it¿s lock).The nurses have stuck themselves because they assume the needle has been completely covered.It was further reported that three nurses have had needle sticks, two of which completed bloodwork themselves and also had the patient¿s blood tested for communicable diseases.One nurse declined bloodwork for her or the patient and declined reporting the event.This report addresses the first needle stick and one of the two nurses who did bloodwork.
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 safety mechanism failure 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 to flush a similar non-complainant device.An attempt to activate the safety mechanism was successful and unremarkable.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.
Event or Problem Description
It was reported that there were two needle stick injuries.It was stated when the needle is pulled and secured back into the safety lock, sometimes the tip will not completely retract into the device (even though it¿s lock).The nurses have stuck themselves because they assume the needle has been completely covered.It was further reported that three nurses have had needle sticks, two of which completed bloodwork themselves and also had the patient¿s blood tested for communicable diseases.One nurse declined bloodwork for her or the patient and declined reporting the event.This report addresses the first needle stick and one of the two nurses who did bloodwork.

• 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: 10522431
• Report Number: 3006260740-2020-03232
• Device Sequence Number: 19621865
• 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