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

Catalog Number	368653
Medical Device Problem Codes	Break (1069); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the bd vacutainer® safety-lok¿ blood collection set with pre-attached holder that the sleeve fell off/ the needle was ruck in the film stopper.This occurred 2 times.The following information was provided by the initial reporter: the customer reported that the rubber sleeve of the np needle fallen off.When dispensing , the rubber sleeve fell into the blood collection tube.When dispensing , the np needle broke at the hub, and the needle and rubber sleeve were stuck in the film stopper of the blood collection tube.
Additional Manufacturer Narrative
E.1 initial reporter facility name: (b)(6).D4.Medical device lot #: unknown.D4.Medical device expiration date: unknown.H4.Device manufacture date: unknown.H.3.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 while using the bd vacutainer® safety-lok¿ blood collection set with pre-attached holder that the sleeve fell off/ the needle was ruck in the film stopper.This occurred 2 times.The following information was provided by the initial reporter: the customer reported that the rubber sleeve of the np needle fallen off.When dispensing , the rubber sleeve fell into the blood collection tube.When dispensing , the np needle broke at the hub, and the needle and rubber sleeve were stuck in the film stopper of the blood collection tube.
Additional Manufacturer Narrative
H.6.Investigation summary: "material #: 368653 lot/batch #: unknown bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the sleeve of the wingset device can be seen detached and stuck in the stopper of a non-bd tube.However, the competitor containment device (blood collection tube) design is not as robust as the bd tubes which have a soft rubber stopper closure that does not allow the sleeve to get caught or hung up.The sleeve compresses on top of the stopper allowing the np needle to pierce through the stopper material.Once removing the tube from the np end, the sleeve then safely retracts back over the np needle (without any leakage) allowing the phlebotomist the opportunity to transfer another tube safely for collection.Other stopper designs in rare cases can trap the wingset sleeve, causing it to pull off, exposing the non-patient (np) needle.Therefore, this complaint cannot be confirmed based on the customer photos provided.In addition, 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.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.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17843634
• Report Number: 1024879-2023-00660
• Device Sequence Number: 17937800
• Product Code: JKA
• UDI-Device Identifier: 50382903686532
• UDI-Public: 50382903686532
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K980414
• 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): 10/10/2023

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: 368653
• 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: 09/05/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 09/29/2023
• Supplement Report FDA Received Date: 10/13/2023
• 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
• Patient Sex: Unknown