MAUDE Adverse Event Report: BECTON DICKINSON BAG ACCESS DEVICE W/CKV; INTRAVASCULAR ADMINISTRATION SET

Model Number	2309E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that a bag access device w/ckv had damaged or defective tubing during use.The following was reported by the initial reporter: "it was reported that there is an issue with the smartsite bag access device.Verbatim: can we please connect with (b)(6) to resolve the matter with item #2309e.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: b.5.Describe event or problem: it was reported that a bag access device w/ckv had damaged or defective tubing during use.The following was reported by the initial reporter: "it was reported that there is an issue with the smartsite bag access device.Once the iv bag is spiked with the smartsite bag access device, the nurse cannot pull back fluid from the bag." verbatim: can we please connect with chad at la county to resolve the matter with item #2309e." d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 12/28/2020 d.4.Medical device lot #: 20076260 d.4.Medical device expiration date: 7/25/2023 h.4.Device manufacture date: 7/9/2020 h.6.Investigation: two samples were returned for investigation.Through visual inspection of the samples, it was observed that the check valve was assembled in the incorrect orientation for one of the samples.No other defects were observed.The two samples were then primed.The misassembled sample could not be primed and could not draw liquid; the customer complaint was verified.A device history record review for model 2309e lot number 20076260 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A complaint history check was performed and this is the 1st related complaint reported with the defect/condition of component damage with lot #20076260 regarding item #2309e.The root cause of this failure was identified as an error during the assembly process.H3 other text : see h.10.
Event or Problem Description
It was reported that a bag access device w/ckv had damaged or defective tubing during use.The following was reported by the initial reporter: "it was reported that there is an issue with the smartsite bag access device.Once the iv bag is spiked with the smartsite bag access device, the nurse cannot pull back fluid from the bag." verbatim: can we please connect with chad at la county to resolve the matter with item #2309e.".

• Brand Name: BAG ACCESS DEVICE W/CKV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11009539
• Report Number: 2243072-2020-02059
• Device Sequence Number: 19049805
• Product Code: FPA
• UDI-Device Identifier: 37613203011663
• UDI-Public: 37613203011663
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2021

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: 07/25/2023
• Device Model Number: 2309E
• Device Catalogue Number: 2309E
• Device Lot Number: 20076260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1