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

Model Number	368652
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	10/14/2022
Type of Reportable Event	Malfunction
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 when using the bd vacutainer® safety-lok¿ blood collection set with pre-attached holder customer has observed debris and dirt inside the sealed device.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "customer problem: customer has observed debris and dirt inside the sealed device 368652 wingset, slbcs 21x.75 12 preattached lot.1285435 exp 10/31/2023.".
Event or Problem Description
It was reported when using the bd vacutainer® safety-lok¿ blood collection set with pre-attached holder customer has observed debris and dirt inside the sealed device.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "customer problem: customer has observed debris and dirt inside the sealed device 368652 wingset slbcs 21x.75 12 preattached lot.1285435 exp 10/31/2023.".
Additional Manufacturer Narrative
The following fields have been updated with additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-10-18.H.6.Investigation summary: bd received 2 samples and 1 photo for investigation.The photo was reviewed and the customer¿s indicated failure mode for foreign matter was observed.The customer samples were evaluated by visual examination and the indicated failure mode for foreign matter with the incident lot was observed as dirt was found in the blister pack and seal.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter was not observed.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 foreign matter.Bd was not able to identify a root cause for the indicated failure mode.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15681883
• Report Number: 1024879-2022-00628
• Device Sequence Number: 6421343
• Product Code: JKA
• UDI-Device Identifier: 50382903686525
• UDI-Public: 50382903686525
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K991088
• 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): 11/14/2022

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: 10/31/2023
• Device Model Number: 368652
• Device Catalogue Number: 368652
• Device Lot Number: 1285435
• 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: 10/15/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 10/27/2022
• Supplement Report FDA Received Date: 11/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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