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

Catalog Number 364314

Device Problems Delivered as Unsterile Product (1421); Product Quality Problem (1506)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported when using the bd preset¿ arterial blood collection syringe the device was found to be bent and without it's protective cap over the bent needle upon opening the device package.No health impact or consequence reported.

Manufacturer Narrative

H.6 investigation summary: 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 missing iv shield / bent cannula 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 missing iv shield / bent cannula.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE
• 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 18159263
• MDR Text Key: 328394924
• Report Number: 9617032-2023-01657
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903643146
• UDI-Public: (01)50382903643146
• 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
• Report Date: 11/15/2023

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: 364314
• Device Lot Number: 3087214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2023
• 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