MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	367341
Medical Device Problem Codes	Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set customer reports that the needle on push button did not fully retract and employee was stuck accidentally.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that needle on push button did not fully retract and employee was stuck accidentally.Did the patient suffer any adverse medical consequences as a result of the change in treatment? did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes.If yes, detailed hazard including any medical intervention: needle on push button did not fully retract and employee was stuck accidentally.
Event or Problem Description
It was reported when using the bd vacutainer® push button blood collection set customer reports that the needle on push button did not fully retract and employee was stuck accidentally.Information regarding intervention was not obtained.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that needle on push button did not fully retract and employee was stuck accidentally.Did the patient suffer any adverse medical consequences as a result of the change in treatment? did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes if yes¿detailed hazard including any medical intervention: needle on push button did not fully retract and employee was stuck accidentally.
Additional Manufacturer Narrative
The following field was updated with corrected information: b.5.Describe event or problem: it was reported when using the bd vacutainer® push button blood collection set customer reports that the needle on push button did not fully retract and employee was stuck accidentally.Information regarding intervention was not obtained.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that needle on push button did not fully retract and employee was stuck accidentally.Did the patient suffer any adverse medical consequences as a result of the change in treatment? did any hazard occur (e.G.Exposure to blood/bodily fluid, needle/probe stick, safety issue)? yes if yes¿detailed hazard including any medical intervention: needle on push button did not fully retract and employee was stuck accidentally.H.6.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17545715
• Report Number: 1024879-2023-00572
• Device Sequence Number: 7420231
• Product Code: JKA
• UDI-Device Identifier: 50382903673419
• UDI-Public: 50382903673419
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• 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): 08/16/2023

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 Catalogue Number: 367341
• 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: 08/07/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 08/14/2023
• Supplement Report FDA Received Date: 08/21/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown