MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) TUBE EDTA PLH 13X75 2.0 SLBL; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368843

Device Problems Fluid/Blood Leak (1250); Component Missing (2306)

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

Event Date 11/30/2023

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 when using the tube edta plh 13x75 2.0 slbl had a cap missing.There was no report of impact to patient or user.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to improper assembly (missing cap) as all samples met specifications.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 improper assembly.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported when using the tube edta plh 13x75 2.0 slbl had a cap missing.There was no report of impact to patient or user.

Manufacturer Narrative

The following fields have been updated with additional information: b5."there was a damaged cap" updated from "there was a missing cap" after clarification from reporter imdrf annex a grid updated from "a020602 - component missing (2306)" to "a050401 - fluid/blood leak (1250)" h.6.Investigation summary: bd received 3 photographs from the customer in support of this complaint showing 1 cap on the tube which are incompletely molded and with a gap in its plastic.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to improper assembly (missing cap) as all samples met specifications.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.Bd was able to duplicate or confirm the customer¿s indicated failure mode based on the photos provided.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.

Event Description

It was reported when using the tube edta plh 13x75 2.0 slbl there was a damaged cap.There was no report of impact to patient or user.

• Brand Name: TUBE EDTA PLH 13X75 2.0 SLBL
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18371886
• MDR Text Key: 331372287
• Report Number: 9617032-2023-01850
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903688432
• UDI-Public: (01)00382903688432
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368843
• Device Lot Number: 3129796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• 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