MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SECURIS STABILIZATION; STAND, INFUSION

Model Number	N/A
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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, applicable previous investigation(s), sample analysis, applicable fmea documents, and labeling.Based on a review of this information, the following was concluded: the complaint of a breach in the seal was confirmed and the cause appeared to be supplier related.Three sealed securis stabilization devices with part number sec0100 and lot #asdxr001 were provided for investigation.The word ¿normal¿ was written on the packaging of two samples.¿complaint sample¿ was written on the packaging of the third sample.The device was not oriented correctly inside the packaging and the corner of the stabilization device was caught in the seal of the ¿complaint sample¿ packaging and was visible through a 1.0cm breach in the seal.The remainder of the seal was intact.The supplier was notified of this complaint.A lot history review (lhr) of asdxr001 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported "while inspecting samples for testing, i found a device that had been sealed into the sterile barrier seal and had breached the sterile barrier.This sample came from for human use product that has been distributed to sales reps.".

• Brand Name: SECURIS STABILIZATION
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10071682
• Report Number: 3006260740-2020-01765
• Device Sequence Number: 766251
• Product Code: FOX
• UDI-Device Identifier: 00801741075452
• UDI-Public: (01)00801741075452
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: Other
• Device Model Number: N/A
• Device Catalogue Number: SEC0100
• Device Lot Number: ASDXR001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Event Location: Other
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1