MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) TUBE PMS PLH 13X75 3.0 PLBL LIM CE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 365050

Device Problems Incorrect Measurement (1383); No Device Output (1435)

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

Event Date 07/02/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that tube pms plh 13x75 3.0 plbl lim ce had a clogged probe.The following information was provided by the initial reporter: "the problem of total or partial clogging began with the routine use of these barricor tubes in march; lots used: 0245299,0311961, 0245299.".

Event Description

It was reported that tube pms plh 13x75 3.0 plbl lim ce had a clogged probe.The following information was provided by the initial reporter: " the problem of total or partial clogging began with the routine use of these barricor tubes in march; lots used: 0245299,0311961, 0245299.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for this evaluation therefore, retention samples from the bd inventory were selected for evaluation.Functional testing was conducted on retention samples from the bd inventory of material #365050, lot(s)# 0245299, 0311961 and 1004602 3.0ml barricror tubes and samples from material #365057, lot# 0311964 5.5ml barricor tubes.Testing was done with blood drawn from subjects and, each tube was run three times on the system with no instrument error codes being observed.Additionally, no difficulties were encountered during blood collection as all tubes appeared to exhibit proper fill and, underfill was not observed in any samples testing.Bd was unable to duplicate or confirm the customer¿s indicated failure of clogged instrumentation (aspiration alarm/ sampling errors) because the alleged defects were not evident in the testing of the bd inventory sample lot samples.All visual observations of both retain and control samples tested demonstrated clinically acceptable performance.Multiple assays performed on cobas instrumentation produced no alarms/error codes.Analytical replicates of both retain and control samples tested were acceptable in terms of both precision and accuracy.The tubes performed as expected therefore, this complaint is unconfirmed for clogged instrumentation (aspiration alarm/ sampling errors).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.H3 other text : see h.10.

• Brand Name: TUBE PMS PLH 13X75 3.0 PLBL LIM CE
• 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12253209
• MDR Text Key: 264316566
• Report Number: 9617032-2021-00845
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Report Date: 11/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 365050
• Device Lot Number: 0245299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2020
• 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