MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD VACUTAINER¿ SODIUM CITRATE BLOOD COLLECTION TUBES; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number UNKNOWN

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Nausea (1970); Vomiting (2144); Convulsion, Clonic (2222); Chemical Exposure (2570)

Event Date 11/01/2019

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)(4) has been listed and the (b)(4) 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: the customer did not provide bd pas with product catalog number or lot number information, when requested.After 3-follow-up attempts to obtain additional information, bd pas has closed this customer complaint.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

Event Description

It was reported that the patient consumed a sodium citrate vacutainer filled with their blood with an unspecified bd vacutainer¿ sodium citrate blood collection tubes.The following information was provided by the initial reporter: caller had call into poison control about a patient who "drank her own blood from a test tube".The lab of the facility stated the bd "test tube" contained sodium citrate.Additional information received: "discussed with caller not exactly sure what was consumed.Vacutainer citrate tubes have 3.2% buffered sodium citrate solution are used for routine coagulation studies (citrate concentration 2.7 ml of 0.109molar/3.2% and 1.8 ml is 0.109molar/3.2%).Bd makes sodium citrate flushes so the risk for ingestion is low however, may cause nausea and vomiting if ingested in large quantities.May also cause hypernoia and convulsing.She found a copy of msds, which states after swallowing: give 2 to 4 glasses of water to dilute.".

• Brand Name: UNSPECIFIED BD VACUTAINER¿ SODIUM CITRATE 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: 9355488
• MDR Text Key: 171979508
• Report Number: 2243072-2019-02604
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• 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: 11/01/2019
• 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