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	Product Quality Problem (1506)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	04/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that kit affirm att system 100 ea caregiver was cut by sharp material with exposure to patient fluid through cut in glove.The following information was provided by the initial reporter: caregiver cut by sharp material after breaking ampule with exposure to patient body fluid through cut in glove.Also had second separate instance of caregiver being cut when opening ampule, but without exposure to body fluid.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that kit affirm att system 100 ea caregiver was cut by sharp material with exposure to patient fluid through cut in glove.The following information was provided by the initial reporter: caregiver cut by sharp material after breaking ampule with exposure to patient body fluid through cut in glove.Also had second separate instance of caregiver being cut when opening ampule, but without exposure to body fluid.
Additional Manufacturer Narrative
H6.Investigation summary: bd integrated diagnostic solutions initiated investigation on the customer report regarding glass user injury while using the affirm atts (catalog # 446255), batch # unknown.Previous investigation did not reveal any changes to materials that could directly cause this injury.A review of past complaints does not indicate trend by atts batch.Bd implemented the packaging of the atts ampule crushing tool in order to prevent future occurrence of this issue.All current atts kits contain 1 tool which will be provided in each kit indefinitely.Per package insert instructions, bd strongly recommends use of this tool to eliminate chance of future injury.We will continue to closely monitor for trends associated with atts glass injury.H3 other text : see h10.

• 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
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 16994730
• Report Number: 9610847-2023-00122
• Device Sequence Number: 17890881
• 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
• Serviced by Third Party (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): 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 446255
• Device Catalogue Number: 446255
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown