MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VACUTAINER® LITHIUM BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

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

Patient Problem Test Result (2695)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

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)(6) has been listed.And the (b)(6) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Additionally, bd was unable to determine the specific material number or lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.The catalog and lot numbers are unknown for this reported event.A review of specimen processing and handling procedures is recommended for this tube type.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Bd will continue to track for additional complaints and emerging trends.

Event Description

It was reported that there were erroneous "critically high" results with an unspecified bd vacutainer® lithium blood collection tubes.The following information was provided by the initial reporter: three years ago a pt blood test came up critically high via green sodium/lithium tube.Pt returned to er; subsequent test with same type tube was normal.

• Brand Name: UNSPECIFIED BD VACUTAINER® LITHIUM BLOOD COLLECTION TUBES
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• 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: 10089807
• MDR Text Key: 195155430
• Report Number: 2243072-2020-00814
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2020
• 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: 05/07/2020
• 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