MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number	367991
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/12/2018
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 that bd vacutainer® sst¿ blood collection tubes had foreign mater in the gel, foreign matter embedded on the tube.
Event or Problem Description
It was reported that bd vacutainer® sst¿ blood collection tubes had foreign matter in the gel in 3 tubes and foreign matter embedded on one tube.
Additional Manufacturer Narrative
The following field was updated due to corrected information: describe event or problem: it was reported that bd vacutainer® sst¿ blood collection tubes had foreign matter in the gel in 3 tubes and foreign matter embedded on one tube.Investigation: investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for fm with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Bd has initiated further investigation relating to this issue through a capa and potential causes have been identified.As a result, corrective actions have been established and are in the process of being implemented.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for fm with the incident lot was observed.Further investigation activities have been conducted through a capa and the most likely root cause has been identified.As a result, corrective actions and procedures are being implemented to mitigate further occurrences.Root cause description: a capa was conducted to document further investigation and root cause analysis relating to this issue.The investigation has identified the most likely root causes and corrective actions are in the process of being implemented.Rationale: based on an assessment of severity and frequency, it was determined that a capa is required at this time in order to determine the root cause associated with this issue.The investigation has identified potential root cause(s) for this issue and corrective actions are in the process of being implemented.

• Brand Name: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 8186920
• Report Number: 1024879-2018-01532
• Device Sequence Number: 2879446
• Product Code: JKA
• UDI-Device Identifier: 00382903679911
• UDI-Public: 382903679911
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: BK050036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2019

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: 09/30/2019
• Device Catalogue Number: 367991
• Device Lot Number: 8278800
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 12/20/2018
• Supplement Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other