MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number	367323
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device type: jka, fpa.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that prior to use it was noticed that the device was partially activated, but not fully retracted with a bd vacutainer® push button blood collection set.The following information was provided by the initial reporter: prior to use, the phlebotomist noticed that the device was partially activated, but had not fully retracted, due to the fact that the needle itself was completely bent and mangled, and was actually hooked to the side of the device, which would not allow the needle to fully retract in to the housing.Pictures were provided by the customer, and luckily, the product was not manipulated or used in any way.
Additional Manufacturer Narrative
H.6 investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for a bent iv needle with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.H3 other text : see h.10.
Event or Problem Description
It was reported that prior to use it was noticed that the device was partially activated, but not fully retracted with a bd vacutainer® push button blood collection set.The following information was provided by the initial reporter: prior to use, the phlebotomist noticed that the device was partially activated, but had not fully retracted, due to the fact that the needle itself was completely bent and mangled, and was actually hooked to the side of the device, which would not allow the needle to fully retract in to the housing.Pictures were provided by the customer, and luckily, the product was not manipulated or used in any way.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 9366168
• Report Number: 1710034-2019-01253
• Device Sequence Number: 3389057
• Product Code: JKA
• UDI-Device Identifier: 50382903673235
• UDI-Public: 50382903673235
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2020

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 Expiration Date: 04/30/2021
• Device Model Number: 367323
• Device Catalogue Number: 367323
• Device Lot Number: 9115996
• Initial Date Received by Manufacturer: 11/07/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 02/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other