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

Catalog Number 364314

Device Problem Filling Problem (1233)

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

Event Date 11/12/2022

Event Type  malfunction  

Manufacturer Narrative

Bd had not received samples or photos for investigation.Therefore, 5 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with colored water, and no issues were observed relating to insufficient flow 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 insufficient blood flow.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported when using the bd preset¿ syringe with attached needle there was insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: "after opening the package, it was found that the needle handle piston of the arterial blood sampler was on the zero scale, had no draw, and could not be used.The other arterial blood sampler was replaced immediately, and no harm was caused to the patient.".

Manufacturer Narrative

The following fields have been updated: 1 photo was provided for re-investigation.Imdrf annex b grid (1): b15 - analysis of data provided by user/third party h.6.Investigation summary: "material #: 364314.Lot/batch #: 2151257.Bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for insufficient blood flow with the incident lot was not observed.Additionally, 5 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to insufficient flow 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 insufficient blood flow.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.

Event Description

It was reported when using the bd preset¿ syringe with attached needle there was insufficient blood flow through the device.The following information was provided by the initial reporter.The customer stated: "after opening the package, it was found that the needle handle piston of the arterial blood sampler was on the zero scale, had no draw, and could not be used.The other arterial blood sampler was replaced immediately, and no harm was caused to the patient.".

• 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: 16025788
• MDR Text Key: 306415238
• Report Number: 9617032-2022-01308
• 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: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 364314
• Device Lot Number: 2151257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2022
• 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