MAUDE Adverse Event Report: BD CARIBE, LTD BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC); SYSTEM, BLOOD CULTURING

Model Number 442020

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

Patient Problem Local Reaction (2035)

Event Date 05/20/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that while using bd bactec¿ peds plus¿/ f culture vials (plastic) blood returned in the blood collection needle when blood was collected from the left inguinofemoral vein.Marble-like spots on the buttocks and lower limbs appeared as a result.This occurred once with one patient.Patient was treated with xiliaoto rubbing and hot and humid compresses to affected area.The following information was provided by the initial reporter: "at 01:30 on (b)(6)2023, when blood was collected from the left inguinofemoral vein of the child, blood returned in the blood collection needle: after connecting the blood culture bottle, the blood in the blood collection needle returned to the blood vessel, and the operator immediately replaced it with a new blue one.A small amount of blood can be seen in the blood collection needle, and the needle is immediately pulled out and pressed, and then "marbled spots" appear, spreading to the buttocks below the abdomen and both lower limbs".

Manufacturer Narrative

H.6.Investigation summary: catalog 442020.Batch no.2299974.Customer reported a vacuum draw issue.Photos were provided.Bd was unable to reproduce customer¿s experience with bactec product.Satisfactory results were obtained from retention samples when visually inspected for any cap defect and leakage.Batch history record review did not identify any evidence for which the customer submitted the complaint.A complaint history review was conducted and only the current complaint was found relating to the incident lot number and the ¿as reported¿ defect code.In addition, five (5) samples were randomly selected, and inspected for any resin trapped between the cap and the mouthpiece with satisfactory results (i.E.No resin observed).Vacuum draw test was performed to retention samples with satisfactory results.Complaint is unconfirmed based on retention samples and batch history record review results.

Event Description

It was reported that while using bd bactec¿ peds plus¿/ f culture vials (plastic) blood returned in the blood collection needle when blood was collected from the left inguinofemoral vein.Marble-like spots on the buttocks and lower limbs appeared as a result.This occurred once with one patient.Patient was treated with xiliaoto rubbing and hot and humid compresses to affected area.The following information was provided by the initial reporter: "at 01:30 on (b)(6), 2023, when blood was collected from the left inguinofemoral vein of the child, blood returned in the blood collection needle: after connecting the blood culture bottle, the blood in the blood collection needle returned to the blood vessel, and the operator immediately replaced it with a new blue one.A small amount of blood can be seen in the blood collection needle, and the needle is immediately pulled out and pressed, and then "marbled spots" appear, spreading to the buttocks below the abdomen and both lower limbs.".

• Brand Name: BD BACTEC¿ PEDS PLUS¿/ F CULTURE VIALS (PLASTIC)
• Type of Device: SYSTEM, BLOOD CULTURING
• Manufacturer (Section D): BD CARIBE, LTD; vicks drive; lot no. 1; cayey PR
• Manufacturer (Section G): BECTON DICKINSON CARIBE LTD.; vicks drive; lot no. 6; cayey PR
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17137511
• MDR Text Key: 317764765
• Report Number: 2647876-2023-00037
• Device Sequence Number: 1
• Product Code: MDB
• UDI-Device Identifier: 00382904420208
• UDI-Public: 00382904420208
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151866
• 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: 08/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 442020
• Device Catalogue Number: 442020
• Device Lot Number: 2299974
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/15/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention