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	07/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using bd vacutainer® safety-lok¿ blood collection set with pre-attached holder the customer observed a doubtful visual aspect on some units.The visible anomaly on the packaging of the products was observed during unpacking.This event occurred 1 time the following information was provided by the initial reporter: "a doubtful visual aspect has been observed on some units.The visible anomaly on the packaging of the products was observed during unpacking.".
Additional Manufacturer Narrative
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 the customer observed a doubtful visual aspect on some units.The visible anomaly on the packaging of the products was observed during unpacking.This event occurred 1 time.The following information was provided by the initial reporter: "a doubtful visual aspect has been observed on some units.The visible anomaly on the packaging of the products was observed during unpacking.".
Additional Manufacturer Narrative
H.6.Investigation summary: "material #: 368652.Lot/batch #: 1167431.Bd received 20 samples and 3 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for foreign matter / cloudy packaging was observed.The customer samples were evaluated by visual examination and the indicated failure mode for foreign matter / cloudy packaging with the incident lot was observed.Additionally, 100 retention samples from bd inventory were evaluated by visual examination and the issue of foreign matter / cloudy packaging 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 / cloudy packaging.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.".

• 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: 15222775
• Report Number: 1024879-2022-00452
• Device Sequence Number: 5887035
• Product Code: JKA
• UDI-Device Identifier: 50382903686525
• UDI-Public: 50382903686525
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2022

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: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 368652
• Device Catalogue Number: 368652
• Device Lot Number: 1167431
• 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: 07/28/2022
• Supplement Date Received by Manufacturer: 09/09/2022
• Initial Report FDA Received Date: 08/14/2022
• Supplement Report FDA Received Date: 09/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• 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