MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 367955

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: a concern of gel exposure was reported to bd.Bd had not received samples, but three (3) photos were provided for investigation.The photos were reviewed and the gel appeared to be scraped or disturbed.The material safety data sheet (sds) was reviewed and it was determined that the gel is not harmful in small quantities and with short periods of exposure.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode of harm-other.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube a child consumed the additive in the tube.The following information was provided by the initial reporter.The customer stated: we live in athens, greece and i visited (b)(6) last week with my 3 years old daughter for her annual blood tests.In order to keep her occupied and calm, the nurse gave her a bd vacutainer sst ii advance tube to play with.She kept it and when we got back home all of a sudden i realized that she opened it and that the gel included in the tube was poured on her hands.Also i don't know if she had placed the gel in her mouth too.I called (b)(6) and they told me not to worry, to wash her hands well and give her some milk.However i wanted to ask you, the manufacturing company as well, if this gel-substance is dangerous for the kid.Further to my previous email, i want to add that my daughter due to constipation (prior to possible gel exposure), she drinks effecol and nujol oil daily.There was no interruption in taking the daily medication after possible gel exposure.The patient continued with medication as indicated throughout the incident.

• Brand Name: BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15203705
• MDR Text Key: 304975846
• Report Number: 9617032-2022-00748
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903679558
• UDI-Public: 50382903679558
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: BK050036
• 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
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2023
• Device Model Number: 367955
• Device Catalogue Number: 367955
• Device Lot Number: 1277556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/04/2021
• 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 Age: 3 YR
• Patient Sex: Female