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

Catalog Number 364391

Device Problems Leak/Splash (1354); Difficult or Delayed Activation (2577)

Patient Problems Foreign Body Sensation in Eye (1869); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2022

Event Type  Injury  

Event Description

It was reported when using the bd preset¿ eclipse¿ with safety needle there was blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip and the device is difficult to use.The following information was provided by the initial reporter.The customer stated: "the syringes are difficult to use and splattered in a technologists eyes.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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¿ with safety needle there was blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip and the device is difficult to use.The following information was provided by the initial reporter.The customer stated: "the syringes are difficult to use and splattered in a technologists eyes.".

Event Description

It was reported when using the bd preset¿ eclipse¿ with safety needle there was blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip and the device is difficult to use.The following information was provided by the initial reporter.The customer stated: "the syringes are difficult to use and splattered in a technologists eyes.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure modes for difficult to use and splatter with the incident lot was not observed.The photos only show an unused syringe still in its packaging and a handwritten paper.Additionally, 10 retention samples from bd inventory were evaluated by functional testing, each drawn with water, and no issues were observed relating to difficult to use or splatter as all samples met specifications.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 modes difficult to use and splatter.Bd was not able to identify a root cause for the indicated failure mode.

• Brand Name: BD PRESET¿ ECLIPSE¿ WITH SAFETY NEEDLE
• 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: 13516073
• MDR Text Key: 285703769
• Report Number: 9617032-2022-00101
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 364391
• Device Lot Number: 0239025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2020
• 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
• Patient Outcome(s): Other