MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2205E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D.4.Medical device lot #: 21065000 was reported, however, this is not a lot # manufactured for the reported catalog #.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.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 while using bd vial access device the needle was damaged.There was no report of patient impact.The following information was provided by the initial reporter: sales reported that: the company's purchasing feedback is not unpacked found puncture head bent needle.Samples can not return, there are photos.No need to claim, need a complaint response letter.
Event or Problem Description
It was reported while using bd vial access device the needle was damaged.There was no report of patient impact.The following information was provided by the initial reporter: sales reported that: the company's purchasing feedback is not unpacked found puncture head bent needle samples can not return, there are photos no need to claim, need a complaint response letter.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 27-jul-2023.H6: investigation summary one 2205e china sample from lot 21065000 was received in sealed packaging for investigation.The feedback provided by the customer suggests the spike of the vial access device (vad) was bent.As part of the feedback the customer provided a photograph of the affected sample; analysis of the photograph as well as a review of the returned sample confirmed the customer's experience, with the spike of the vad identified to be damaged and bent.The details of this feedback were forwarded to the manufacturing site for investigation.A definitive root cause for the customer's experience could not be determined, however they confirmed that such damage may have occurred during the automatic assembly process of the vad.A review of the production records for lot 21065000 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

• Brand Name: BD VIAL ACCESS DEVICE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17452679
• Report Number: 9616066-2023-01637
• Device Sequence Number: 20655201
• Product Code: FPA
• UDI-Device Identifier: 07613203011778
• UDI-Public: (01)07613203011778
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K970485
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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: 2205E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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