MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MINILOC SAFETY INFUSION SET 20G X 1 IN; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not yet been returned for evaluation.
Event or Problem Description
It was reported by the customer that the security lock was broken on the device.
Additional Manufacturer Narrative
The device has not been returned, at this time, to the manufacturer for evaluation.A lot history review (lhr) of ascss0228 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that the security lock was broken on the 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, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged safety mechanism wing is confirmed but the exact cause and location at which it occurred could not be determined from the sample returned.One 20 ga x 1 in miniloc safety infusion set was returned for investigation in open packaging.The packaging contained lot: ascss0228.The blue end cap was returned attached, the safety mechanism was not activated, and no apparent use residue was present within the device.One of the clear wing tabs from the safety mechanism was returned broken off.Microscopic observation of the break surface revealed the surface to be uneven and angled.The top edge was observed to be curved upward.This is suggestive of an uneven force being applied to the infusion set.The safety mechanism was advanced and able to be activated successfully.Since the clear wing tab was broken from the safety mechanism, the complaint was confirmed; however, the cause was unknown.A lot history review (lhr) of ascss0228 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the customer that the security lock was broken on the device.

• Brand Name: MINILOC SAFETY INFUSION SET 20G X 1 IN
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8480439
• Report Number: 3006260740-2019-00769
• Device Sequence Number: 19200416
• 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: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/28/2019

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
• Device Lot Number: ASCSS0228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/28/2019; 06/13/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/30/2019; 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1