MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) TUBE LIHEP PLH 13X75 4.0 PLBL GN; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 367884

Device Problems Coagulation in Device or Device Ingredient (1096); Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 04/02/2024

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 lihep plh 13x75 4.0 plbl gn there were white particles in the tube after centrifugation (clotting), thus resulting in critical value results for the customer (erroneous result).No treatment change was reported.

• Brand Name: TUBE LIHEP PLH 13X75 4.0 PLBL GN
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19182346
• MDR Text Key: 341268154
• Report Number: 1917413-2024-00359
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678841
• UDI-Public: (01)50382903678841
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K945952
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 367884
• Device Lot Number: 3222747
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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