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 Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 01/19/2024

Event Type  malfunction  

Event Description

It was reported when using the tube lihep plh 13x75 4.0 plbl gn there was one tube with a crack.There was no report of impact to patient or user.

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.E.4.Initial reporter facility name: (b)(6) hospital.

Event Description

It was reported when using the tube lihep plh 13x75 4.0 plbl gn there was one tube with a crack.There was no report of impact to patient or user.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 2 photos were provided for investigation.The photos were reviewed and the indicated failure mode for damaged product/component with the incident lot was not observed.The photos show an unused tube and a tube on the counter with blood drops around and under the tube.It cannot be determined if there is damage to the tube.Additionally,100 retention samples from bd inventory were visually inspected with no issues observed.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, damage to product/component.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.

• 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: 18784403
• MDR Text Key: 337310892
• Report Number: 1917413-2024-00138
• 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,Followup
• Report Date: 04/11/2024

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 Catalogue Number: 367884
• Device Lot Number: 3136190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• 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