MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	367352
Medical Device Problem Codes	Physical Resistance/Sticking (4012); Separation Problem (4043)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 during use with bd vacutainer® push button blood collection set with pre-attached holder when the button was pressed to retract the needle the needle separated and hit the patient and the nurse.Blood tests to check for infection was performed on the patient and the nurse.The following information was provided by the initial reporter: customer stated using the butterly to draw blood from right ac, she drew two tubes.As soon as she touched the button to retract the needle, the needle bounced back hit patient on forearm and hit nurse on the thumb.Nurse washed affected areas on nurse and patient with soap and water.Did the specimen(s) need to be recollected? no.Did exposure to blood/ bf occur? yes.If exposure occurred was there any post exposure testing or medical intervention? yes, blood was drawn on patient and nurse to check for infection.
Additional Manufacturer Narrative
The following fields were updated with additional information: d.10 device available for eval? yes d.10 returned to manufacturer on: 17-feb-2023 h.6.Investigation summary: bd received [2] photos and [12] samples for investigation.2 customer photos and 12 customer samples were received for review and evaluation.One customer photo shows the product packaging, and the other photo shows a used device with front/rear barrel separation.Therefore, this complaint can be confirmed based on the customer photo provided.Bd is able to confirm the failure mode of separates during use based on customer photo analysis.Bd is unable to confirm the customer¿s reported failure mode of needle stick ¿ after use/dirty based on customer photo analysis.In addition, the 12 customer samples were subjected to a draw test followed by retraction lockout testing to assess for any issues during activation of the safety mechanism.All samples passed testing as they were able to be activated properly.Therefore, this complaint cannot be confirmed based on customer sample testing results.Bd is unable to confirm the customer¿s reported failure mode of retraction issue based on customer sample testing analysis.Bd is unable to confirm the customer¿s reported failure mode of needle stick ¿ after use/dirty based on customer sample testing analysis.Based on a review of batch records, no root cause from manufacturing was identified as a contributor.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that during use with bd vacutainer® push button blood collection set with pre-attached holder when the button was pressed to retract the needle the needle separated and hit the patient and the nurse.Blood tests to check for infection was performed on the patient and the nurse.The following information was provided by the initial reporter: customer stated using the butterly to draw blood from right ac, she drew two tubes.As soon as she touched the button to retract the needle, the needle bounced back hit patient on forearm and hit nurse on the thumb.Nurse washed affected areas on nurse and patient with soap and water.Did the specimen(s) need to be recollected? no did exposure to blood/ bf occur? yes if exposure occurred was there any post exposure testing or medical intervention? yes, blood was drawn on patient and nurse to check for infection.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16448354
• Report Number: 1024879-2023-00107
• Device Sequence Number: 5844046
• Product Code: FPA
• UDI-Device Identifier: 50382903673525
• UDI-Public: (01)50382903673525
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 04/26/2023

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 Expiration Date: 07/31/2024
• Device Model Number: 367352
• Device Catalogue Number: 367352
• Device Lot Number: 2208086
• 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: 02/10/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 02/27/2023
• Supplement Report FDA Received Date: 04/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2022
• 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
• Patient Sex: Unknown