MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, complaint and batch history, labeling, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing packaging sheath on an infusion set was inconclusive due to the sample condition.The products returned for evaluation were two 20g x 1¿ miniloc safety infusion sets and their opened packaging.The samples were free of residual material, contained the end caps on the luer adaptors, and the infusion set tubing clamped.The first sample analyzed was received with the packaging sheath over the needle and without the safety mechanism activated.The second sample was received without the packaging sheath over the needle.The safety mechanism had been engaged over the needle on this sample.Although the packaging sheath was not on the needle, it could not be confirmed when this occurred.Possible causes could include the sheath not being inserted onto the needle during manufacturing, the packaging sheath dislodging in the packaging, or the sheath falling off prior to use.Because the packaging had been opened, it could not be confirmed whether the needle sheath had been included in the package or not.A lot history review (lhr) of asdrs0064 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Customer reports that protective cover is missing.On (b)(6) 2021- the protective cover was missing from the needle itself.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11238198
• Report Number: 3006260740-2021-00071
• Device Sequence Number: 19794012
• Product Code: FPA
• UDI-Device Identifier: 00801741048722
• UDI-Public: (01)00801741048722
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K050600
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/12/2021

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: S02020-10-BARD
• Device Lot Number: ASDRS0064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other