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	Foreign Body In Patient (2687)
Date of Event	02/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd molecular quality initiated investigation on the customer report regarding glass user injury while using the affirm atts.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 has implemented 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.Bd deeply apologizes for any issues this incident has caused.We will continue to closely monitor for trends associated with atts glass injury.If you have any additional questions or concerns, please do not hesitate to contact bd technical services.
Event or Problem Description
It was reported that while using kit affirm att system 100 ea the laboratory personnel had their skin punctured while breaking an ampule with patient sample.First aid was applied and there was no other impact reported.
Additional Manufacturer Narrative
It was determined in review of this record that the incorrect guideline was used to complete the decision tree for this product.A new not reportable decision tree has been completed using the minor first aid guidelines instead.After review it was determined that the sample was not a patient sample.This mdr should be considered cancelled.
Event or Problem Description
It was reported that while using kit affirm att system 100 ea the laboratory personnel had their skin punctured while breaking an ampule with no patient sample.First aid was applied and there was no other impact reported.

• 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: 11565891
• Report Number: 9610847-2021-00113
• Device Sequence Number: 4183251
• Product Code: LIO
• UDI-Device Identifier: 30382904462551
• UDI-Public: 30382904462551
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 04/05/2021

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: 08/30/2021
• Device Model Number: 446255
• Device Catalogue Number: 446255
• Device Lot Number: B03C115M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1