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

Catalog Number	368654
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: d4.Medical device lot#: 4197890; d4.Medical device expiration date: 30-jun-2026; h4.Device manufacture date: 19-aug-2024; unique identifier (udi) #: (b)(4).D4.Medical device lot#: 4199479; d4.Medical device expiration date: 30-jun-2026; h4.Device manufacture date: 05-aug-2024; unique identifier (udi) #: (b)(4).Date of event is unknown.The date received by manufacturer has been used for this field.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 that while using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, there were particles and foreign bodies observed in 64 units on lot number 4150858, and 1 unit for batches 4197890 and 4199479.No patient impact reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 07-oct-2024.Investigation summary: material #:368654.Lot/batch #: 4150858, 4197890, 4199479.Bd received 10 samples and 15 customer photos for lot number 4150858, and 1 photo from lot 4197890 for investigation.The 15 customer photos for lot number 4150858 were reviewed and the indicated failure mode for foreign matter-unknown was observed.Additionally, the 10 customer samples were evaluated by visual examination and the issue of foreign matter was observed.However, the specific type of foreign matter could not be confirmed.In addition, the 1 customer photo from lot 4197890 shows a device with a piece of dark foreign matter in the packaging, but the 70 retain samples from the same lot 4197890 which was subjected to visual inspection did not show foreign matter.Also, 100 retain samples from lot 4199479 were visually inspected for foreign matter in the device packaging and all samples passed testing exhibiting no foreign matter in the packages.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for the indicated failure mode of foreign matter- unknown for lot number 4150858 based on the returned sample testing and the photo analysis.Also, the complaint is confirmed for the indicated failure mode of foreign matter- unknown for lot number lot number 4197890 based on the photo analysis and unconfirmed for foreign matter- unknown for lot number 4199479 based on retain testing.Bd was not able to identify a root cause for the indicated failure mode.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.".
Event or Problem Description
It was reported that while using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder, there were particles and foreign bodies observed in (b)(4) units on lot number 4150858, and (b)(4) unit for batches 4197890 and 4199479.No patient impact reported.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20454910
• Report Number: 1024879-2024-00934
• Device Sequence Number: 20594307
• Product Code: JKA
• UDI-Device Identifier: 00382903686544
• UDI-Public: (01)00382903686544(11)240620(17)260531(10)4150858
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/18/2024

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 Expiration Date: 05/31/2026
• Device Catalogue Number: 368654
• Device Lot Number: 4150858
• 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: 09/16/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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