MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ ECLIPSE¿; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 364390

Device Problem Component Misassembled (4004)

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

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

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 preset¿ eclipse¿, the device experienced failure of the product to contain blood.The amount of occurrence is unclear but an estimated amount of 500 products were noted.The following information was provided by the initial reporter.The customer stated: syringes with improperly capped samples and spilled samples are received in the laboratory.They have received in the laboratory samples from all over the hospital that had spilled in transport because the caps did not close properly.They have seen that it seems that the caps themselves do not have the thread properly made to connect properly with the luer lok cone of the syringes.They are not clear about the affected lot because from the warehouse they are distributed throughout the hospital and from the services where they take the samples they have not noticed that the stopper did not connect correctly, it was in the laboratory when they received them when they detected that the sample had spilled during transport and they have no way of knowing which was the lot of the product.

Manufacturer Narrative

The following fields were updated due to additional information: multiple lot numbers: there were multiple lot numbers reported to be involved.The information for the additional lot number is as follows: d.4.Medical device lot #: 2182401.D.4.Medical device expiration date: 2024-06-30.H.4.Device manufacture date: 2022-07-01.D9: device available for eval: yes.D9: returned to manufacturer on: 2022-10-05.H.6.Investigation summary: "material #: 364390.Lot/batch #: 2182401 & 2172749.Bd received 6 samples and 1 photo for investigation.The photo was reviewed and the indicated failure mode for loose cap causing leakage was observed.Additionally, the customer samples along with 10 retention samples from bd inventory, were evaluated by functional testing, each drawn with water and all hemogard caps were tightened to the syringe.The issue of loose cap was not 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 has been confirmed for the indicated failure mode loose cap.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd preset¿ eclipse¿, the device experienced failure of the product to contain blood.The amount of occurrence is unclear but an estimated amount of 500 products were noted.The following information was provided by the initial reporter.The customer stated: syringes with improperly capped samples and spilled samples are received in the laboratory.They have received in the laboratory samples from all over the hospital that had spilled in transport because the caps did not close properly.They have seen that it seems that the caps themselves do not have the thread properly made to connect properly with the luer lok cone of the syringes.They are not clear about the affected lot because from the warehouse they are distributed throughout the hospital and from the services where they take the samples they have not noticed that the stopper did not connect correctly, it was in the laboratory when they received them when they detected that the sample had spilled during transport and they have no way of knowing which was the lot of the product.

• Brand Name: BD PRESET¿ ECLIPSE¿
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15474404
• MDR Text Key: 304979882
• Report Number: 9617032-2022-00945
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K022426
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364390
• Device Lot Number: 2172749
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2022
• 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