MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ CONTAINMENT TUBE

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos from your facility for evaluation; therefore, the investigation was limited.Additionally, we were unable to determine the specific catalog or lot number associated with this complaint.Therefore, a review of the manufacturing records could not be conducted.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

Event Description

It has been reported that the unspecified bd¿ containment tube has been in use after expiration date.The following has been provided by the initial reporter: warehouse storage time is too long, product failure.

• Brand Name: UNSPECIFIED BD¿ CONTAINMENT TUBE
• Type of Device: CONTAINMENT TUBE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9286483
• MDR Text Key: 173453840
• Report Number: 2243072-2019-02484
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/22/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other