MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (SPARKS) BD BBL¿ VENTING UNIT; MONITOR, MICROBIAL GROWTH

Model Number	271056
Medical Device Problem Code	Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while using bd bbl¿ venting unit the customer encountered some resistance removing sub vent, and when it came out, they accidentally stuck themselves in the hand.This event occurred 1 time.The following information was provided by the initial reporter: "technician encountered some resistance removing sub vent, and when it came out, they accidentally stuck themselves in the hand.Technician was started on bactrim due to patient of culture having mrsa.Patient of culture was negative for hiv, hepatitis b and hepatitis c.".
Additional Manufacturer Narrative
Medical device expiration date: unknown.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 bbl¿ venting unit the customer encountered some resistance removing sub vent, and when it came out, they accidentally stuck themself in the hand.This event occurred 1 time the following information was provided by the initial reporter: "technician encountered some resistance removing sub vent, and when it came out, they accidentally stuck themself in the hand.Technician was started on bactrim due to patient of culture having mrsa.Patient of culture was negative for hiv, hepatits b and hepatitis c.".
Additional Manufacturer Narrative
Investigation summary this complaint is for a customer experiencing a needle stick when using sterile ub/vent unit for culture bottle (catalog # 271056) batch #211005.The bd venting needle is used by lab technicians for venting blood culture bottles and subculture of the blood bottle through the placement of drops of blood culture broth onto plated media.It was reported by the customer that the technician encountered some resistance removing the sub vent and when it came out, they accidentally stuck themselves in the hand.The customer did not provide product returns or photos for the investigation.The complaint record does not specify whether or not the user was wearing ppe (including gloves) during the incident.To investigate, retention samples of the complaint batch were manually and visually inspected for defects.No defects were observed during the manual visual inspection.As a result, this complaint is not confirmed.A review of the product labeling for this batch confirmed that current product labeling includes the appropriate warnings.A review of quality notifications revealed no quality notifications generated on the complaint batch.Complaint trending was performed, and no trends were identified associated with this defect.Based on a review of complaints over the last year and the occurrence of this incident, no further corrective action is required.Bd id/ast plant quality will continue to monitor for trends and take action as necessary.

• Brand Name: BD BBL¿ VENTING UNIT
• Common Device Name: MONITOR, MICROBIAL GROWTH
• Manufacturer (Section D): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer (Section G): BECTON, DICKINSON & CO. (SPARKS); 7 loveton circle; sparks MD 21152
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15161353
• Report Number: 1119779-2022-01062
• Device Sequence Number: 6167569
• Product Code: JTA
• UDI-Device Identifier: 30382902710562
• UDI-Public: 30382902710562
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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): 02/17/2023

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: Health Professional
• Device Model Number: 271056
• Device Catalogue Number: 271056
• Device Lot Number: 211005
• 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: 07/12/2022
• Supplement Date Received by Manufacturer: 02/17/2023
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown