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

Catalog Number 364314

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 05/26/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: "material #: 364314.Lot/batch #: 1299054.Bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to incorrect plunger stopper position 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 incorrect plunger stopper position.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.".

Event Description

It was reported when using the bd preset¿ syringe with attached needle found that the plunger of the arterial blood collection device was on zero scale and had no negative pressure, so it could not be used.The following information was provided by the initial reporter.The customer stated: ¿after opening the package, it was found that the plunger of the arterial blood collection device was on zero scale and had no negative pressure, so it could not be used.".

Event Description

It was reported when using the bd preset¿ syringe with attached needle found that the plunger of the arterial blood collection device was on zero scale and had no negative pressure, so it could not be used.The following information was provided by the initial reporter.The customer stated: ¿after opening the package, it was found that the plunger of the arterial blood collection device was on zero scale and had no negative pressure, so it could not be used.".

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for plunger stopper in wrong position was observed as the plunger was pushed to the end of the syringe.Additionally, 10 retention samples from bd inventory were evaluated by visual examination and the issue of plunger stopper in wrong position 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 plunger stopper in wrong position.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.

• Brand Name: BD PRESET¿ SYRINGE WITH ATTACHED 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: 15018658
• MDR Text Key: 296175731
• Report Number: 9617032-2022-00645
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/02/2023

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 Expiration Date: 11/30/2023
• Device Catalogue Number: 364314
• Device Lot Number: 1299054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2022
• Initial Date FDA Received: 07/14/2022
• Supplement Dates Manufacturer Received: 02/02/2023
• Supplement Dates FDA Received: 02/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2021
• 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