MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. KIT AFFIRM ATT SYSTEM 100 EA; DEVICE, SPECIMEN COLLECTION

Model Number	446255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that while using kit affirm att system 100 ea the tip of the swab broke off inside the patient.This could lead to serious injury and necessitate medical intervention.There was no report of patient impact.
Additional Manufacturer Narrative
H6: investigation summary bd molecular quality initiated investigation on the customer report regarding an incident where during patient specimen collection an affirm swab head detached.Quality investigation required vendor investigation.Our swab manufacturer (vendor) reviewed the batch history records for the batch in question and no discrepancies were noted.The vendor performed inspections and testing of retention materials from the reported batch and no failures were encountered.Our vendor was unable to duplicate/confirm the customers report.The vendor reviewed the past year of complaints against this swab product and there was one other complaint related to swab head detachment (which was submitted from the same end user as this complaint).Several inquiries were made with the end user in attempts to determine if the same doctor or clinician performed the collection of both (the two) reported incidents, however, no response was received.See h10.
Event or Problem Description
It was reported that while using kit affirm att system 100 ea the tip of the swab broke off inside the patient.This could lead to serious injury and necessitate medical intervention.There was no report of patient impact.

• Brand Name: KIT AFFIRM ATT SYSTEM 100 EA
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• MDR Report Key: 11254338
• Report Number: 9610847-2021-00049
• Device Sequence Number: 14500245
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: 30382904462551
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K920536
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2021

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: Other
• Device Expiration Date: 02/28/2022
• Device Model Number: 446255
• Device Catalogue Number: 446255
• Device Lot Number: B01C269M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/04/2021
• Initial Report FDA Received Date: 01/29/2021
• Supplement Report FDA Received Date: 02/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1