MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368159

Device Problems Coagulation in Device or Device Ingredient (1096); Short Fill (1575); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/09/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter name and address: phone: (b)(6).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 bd vacutainer® sst¿ blood collection tubes, the device experienced air bubbles in gel, foreign matter, underfill or low draw of a tube with blood, use of an expired tube.These events occurred: underfill occurred 5 times.Foreign matter 15 times.Air bubbles in gel 38 times.Use of an expired tube once.The following information was provided by the initial reporter.The customer stated: yesterday, in outpatient care for sample collection, the technicians reported that the vacutainer tubes with gel did not fill adequately with the blood sample; so when they saw the expiration date, they detected that it indicated 09-30-2021.It should be noted that there were also problems in taking hospitalized patients.These cases were 5 in total, so the tubes that had already been punctured were discarded.This situation does not fit me, since we do not have material from last year in stock.We are currently still using the tubes with expiration date 10-31-2022.Given this situation, i asked the assistant to check all the tubes from now on when removing them from their original packaging, since in reality said packaging does not show alterations, and the tubes around the closed packaging reflect that date 10-31-22.But in the middle of the package that was opened, these 10 tubes were found with the expiration date of 09-30-2021.When doing the intensive search, alterations were also found in the gel, several with bubbles in the gel as unconsolidated and even one with foreign matter.In this case, there are 15 damaged or badly dated tubes from a pack of 100, for example.

Manufacturer Narrative

The following fields have been updated with additional information: d.10 device available for eval? yes.D.10 returned to manufacturer on: 09-jan-2023.Three (3) customer photos and one hundred (100) customer samples were received for review and analysis.After review and analysis of the customer photos, bd is able to confirm gel airbubbles, foreign matter-unknown, and expired (as the tubes that they were using that included batch# 1305669 were expired at the time of use).Additionally, bd is unable to confirm damaged and draw volume.Additionally, 30 retain samples were subjected for visual inspection for all defects.0 of 30 retain samples failed.Therefore, bd is unable to duplicate any of the customer reported defects listed above.In addition, retain testing for batch# 1305669 cannot be completed because the samples were past the expiration date.Product expired on 10/31/2022 additionally, 30 of the 100 customer samples were randomly selected and subjected to visual inspection for damage, foreign matter, and gel airbubbles.28 of 30 customer samples failed for gel airbubbles, 2 of 30 customer samples failed for fm, and 0 of 30 customer samples failed for damage.For the incorrect date with the ten different lot numbers, dhr records were checked with no difference in batch numbers that were on each label that is placed at the beginning of each roll.Additionally, once a batch is completed and there is a batch change, all batch labels not used from the previous batch are thrown away before a full batch change is completed.Bd makes no claims on expired products.The device history record was reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.Based on a review of batch records and the investigation results, no root cause from the manufacturing process has been identified as a contributor.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.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 bd vacutainer® sst¿ blood collection tubes, the device experienced air bubbles in gel, foreign matter, underfill or low draw of a tube with blood, use of an expired tube.These events occurred: underfill occurred 5 times.Foreign matter 15 times.Air bubbles in gel 38 times.Use of an expired tube once.The following information was provided by the initial reporter.The customer stated: yesterday, in outpatient care for sample collection, the technicians reported that the vacutainer tubes with gel did not fill adequately with the blood sample; so when they saw the expiration date, they detected that it indicated 09-30-2021.It should be noted that there were also problems in taking hospitalized patients.These cases were 5 in total, so the tubes that had already been punctured were discarded.This situation does not fit me, since we do not have material from last year in stock.We are currently still using the tubes with expiration date 10-31-2022.Given this situation, i asked the assistant to check all the tubes from now on when removing them from their original packaging, since in reality said packaging does not show alterations, and the tubes around the closed packaging reflect that date 10-31-22.But in the middle of the package that was opened, these 10 tubes were found with the expiration date of 09-30-2021.When doing the intensive search, alterations were also found in the gel, several with bubbles in the gel as unconsolidated and even one with foreign matter.In this case, there are 15 damaged or badly dated tubes from a pack of 100, for example.

• Brand Name: BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer (Section G): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15886396
• MDR Text Key: 307807639
• Report Number: 1024879-2022-00695
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 01/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: 368159
• Device Lot Number: 1305669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2021
• 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