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

Catalog Number 246001

Device Problems Break (1069); Protective Measures Problem (3015)

Patient Problem Injury (2348)

Event Date 01/09/2019

Event Type  Injury  

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 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.

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 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
• Type of Device: CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 250 schilling circle; cockeysville MD 21030
• MDR Report Key: 8294420
• MDR Text Key: 134694234
• Report Number: 1111096-2019-00101
• Device Sequence Number: 1
• Product Code: JSG
• UDI-Device Identifier: 30382902460016
• UDI-Public: 30382902460016
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Other
• Device Catalogue Number: 246001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 01/09/2019
• Supplement Dates FDA Received: 02/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other