MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 368835

Device Problem Leak/Splash (1354)

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

Event Date 10/05/2023

Event Type  malfunction  

Event Description

It was reported that while using bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder, the rubber sleeve leaked.This event occurred 1 time.The following information was provided by the initial reporter: rubber sleeve leaked.Hus has had now these cases before already (pirs done).

Manufacturer Narrative

D1: medical device brand name: bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder.H.6.Investigation summary: bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 vacutainer tubes, and no issues were observed relating to sleeve leakage 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 mode sleeve leakage.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.".

Manufacturer Narrative

H.6.Investigation summary: bd received 48 samples for investigation.Ten (10) of the samples were chosen at random and evaluated by functional testing, each used to draw 6 vacutainer tubes, and the indicated failure mode for sleeve leakage with the incident lot was not observed.Additionally, 10 retention samples from bd inventory were evaluated by functional testing, each used to draw 6 vacutainer tubes, and no issues were observed relating to sleeve leakage 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 mode sleeve leakage.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.D.1.Device available for eval: yes.D.1.Returned to manufacturer on: 07-nov-2023.

Event Description

It was reported that while using bd vacutainer® eclipse¿ signal¿ blood collection needle with integrated holder, the rubber sleeve leaked.This event occurred 1 time.The following information was provided by the initial reporter: rubber sleeve leaked.Hus has had now these cases before already (pirs done).

• Brand Name: SEE H.10
• 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: jennifer suh ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18012353
• MDR Text Key: 327756970
• Report Number: 9617032-2023-01553
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 30382903688358
• UDI-Public: (01)30382903688358
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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: 11/14/2023

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: 368835
• Device Lot Number: 3151080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/09/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 11/14/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• 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