MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ TUBE

Catalog Number UNKNOWN

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/15/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: 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.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that hemolysis was seen with unspecified bd¿ tube.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: bd had made multiple attempts to reach the customer in order to gather more information on the catalog and lot number; however, bd had not received a response from the customer.A good faith effort has been made and this complaint will be closed without further investigation at this time.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Hemolysis can be caused by many sources, including certain patient pathological conditions, improper specimen collection, specimen processing, and specimen transport.Specimen collection factors that can contribute to hemolysis range from prolonged tourniquet time and improper venipuncture technique to transferring a sample from a syringe draw or iv catheter.Specimen processing factors include vigorous mixing or shaking of the specimen, not allowing the specimen to clot for the recommended amount of time, prolonged contact of serum or plasma with cells, and exposure to excessive heat or cold.Finally, mechanical trauma and other adverse conditions during transport of tubes can result in hemolysis.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that hemolysis was seen with unspecified bd¿ tube.No serious injury or medical intervention was reported.

• Brand Name: UNSPECIFIED BD¿ TUBE
• Type of Device: 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 ; 8015652845
• MDR Report Key: 8206839
• MDR Text Key: 131913944
• Report Number: 2243072-2018-01898
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2018
• 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: 12/15/2018
• 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