MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) KIT AFFIRM ATT SYSTEM 100 EA; DEVICE, SPECIMEN COLLECTION

Catalog Number	446255
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.6.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, we will continue to closely monitor for trends associated with atts glass injury.
Event or Problem Description
It has been reported that the kit affirm att system 100 ea has been found with the ampule puncturing skin during use.No serious injury was reported, first aide provided.The following has been provided by the initial reporter: aff 446255 injury when breaking the ampule.Customer reports an injury when breaking the ampule: a small pinpoint break in skin.First aide provided (cleansed and band aid applied); no further treatment required.

• Brand Name: KIT AFFIRM ATT SYSTEM 100 EA
• Common Device Name: DEVICE, SPECIMEN COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18243294
• Report Number: 1119779-2023-01282
• Device Sequence Number: 7059614
• Product Code: LIO
• UDI-Device Identifier: 00382904462550
• UDI-Public: (01)00382904462550
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 11/11/2023

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 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: 11/08/2023
• Initial Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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
• Patient Sex: Unknown