MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD PHOENIX¿ ID BROTH; CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL

Catalog Number	246001
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device expiration date: unknown.No lot # provided.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that while opening a box of bd phoenix¿ id broth tubes, a lab technician cut their hand on a broken glass tube that was loose inside the box.
Additional Manufacturer Narrative
Investigation summary: this complaint is for broken glass in a box of id broth, catalog 246001.There was no batch number provided.A photo of an empty box interior was received from the customer.The photo showed broken glass, but no batch or product information was visible.Since no batch number was provided on the complaint or in the photo it was not possible to review quality notification trends for the batch.Complaint trending was performed and no trends were identified for these defects.A review of the photo was completed.Because no batch or product information is available, the complaint is not confirmed.Because no trends were identified no further corrective action required.Bd will continue to monitor trends.
Event or Problem Description
It was reported that while opening a box of bd phoenix¿ id broth tubes, a lab technician cut their hand on a broken glass tube that was loose inside the box.

• Brand Name: BD PHOENIX¿ ID BROTH
• Common Device Name: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 250 schilling circle; cockeysville MD 21030
• MDR Report Key: 8294420
• Report Number: 1111096-2019-00101
• Device Sequence Number: 11260494
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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): 02/18/2019

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 Catalogue Number: 246001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/09/2019
• Supplement Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/31/2019
• Supplement Report FDA Received Date: 02/18/2019
• 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