MAUDE Adverse Event Report: BECTON DICKINSON CARIBE LTD. BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS; BLOOD CULTURE

Catalog Number	442193
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Injury (2348)
Date of Event	06/28/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Investigation: investigation summary: customer reported a broken bottle defect.Photos of a broken bottle were provided.Investigation conclusion: bd was unable to reproduce customer's experience with the bactec product.Satisfactory results were obtained from retention samples when visually inspected for any broken and/or cracked vials.Batch history record review did not identify any evidence for which the customer submitted the complaint.Complaint is unconfirmed based retention samples and batch history record review results.Bd recommends the use of bd bactec¿ safepod system or equivalent for safe transportation of bactec bottles.Letter #: (b)(4) should be provided to the customer.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.Root cause description: no root cause was determine, complaint could not be confirmed.
Event or Problem Description
It was reported that while handling bd bactec¿ plus anaerobic/f culture vials, a glass vial broke in the user's hand causing blood to splash out of the vial and a minor cut on the customers hand which resulted in exposure to collected blood from the vial.
Event or Problem Description
It was reported that while handling bd bactec¿ plus anaerobic/f culture vials, a glass vial broke in the user's hand causing blood to splash out of the vial and a minor cut on the customers hand which resulted in exposure to collected blood from the vial.
Additional Manufacturer Narrative
Investigation summary: bd was unable to reproduce customer's experience with the bactec product.Satisfactory results were obtained from retention samples when visually inspected for any broken and/or cracked vials.Batch history record review did not identify any evidence for which the customer submitted the complaint.Complaint is unconfirmed based retention samples and batch history record review results.Bd recommends the use of bd bactec¿ safepod system or equivalent for safe transportation of bactec bottles.Letter #: shq-170 should be provided to the customer.A cross functional team continually monitors all product complaints for trends and determines if any additional actions are necessary beyond the current investigation process.Investigation conclusion: no root cause was determine, complaint could not be confirmed.
Event or Problem Description
It was reported that while handling bd bactec¿ plus anaerobic/f culture vials, a glass vial broke in the user's hand causing blood to splash out of the vial and a minor cut on the customers hand which resulted in exposure to collected blood from the vial.
Additional Manufacturer Narrative
Correction: type of reportable events: serious injury.
Additional Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention.Device single use?: no.Device returned to manufacture: no.
Event or Problem Description
It was reported that while handling bd bactec¿ plus anaerobic/f culture vials, a glass vial broke in the user's hand causing blood to splash out of the vial and a minor cut on the customers hand which resulted in exposure to collected blood from the vial.

• Brand Name: BD BACTEC¿ PLUS ANAEROBIC/F CULTURE VIALS
• Common Device Name: BLOOD CULTURE
• Manufacturer (Section D): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• MDR Report Key: 7709434
• Report Number: 2647876-2018-00020
• Device Sequence Number: 13683062
• Product Code: MDB
• UDI-Device Identifier: 00382904421939
• UDI-Public: 00382904421939
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K921133
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/28/2018

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 Expiration Date: 06/30/2018
• Device Catalogue Number: 442193
• Device Lot Number: 7145893
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 06/28/2018; 06/28/2018; 06/28/2018
• Initial Report FDA Received Date: 07/22/2018
• Supplement Report FDA Received Date: 08/21/2018; 08/22/2018; 09/07/2018
• 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: Required Intervention