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

Catalog Number 364314

Device Problem Short Fill (1575)

Patient Problem Discomfort (2330)

Event Date 03/19/2023

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd preset¿ arterial blood collection syringe, there was insufficient blood flow through one device.No patient impact reported.The following information was provided by the initial reporter: (b)(6) 2023.The patient came to the rescue room due to unconsciousness, after admission to the hospital in accordance with medical advice given to the patient's arterial blood collection to check the patient's body metabolism, take a new arterial blood collection device in accordance with the norms of blood collection for blood collection, after puncture bleeding status is good, the blood back to the needle plug, should be blocked in this way the blood, but this time the blood collection of blood seepage into the needle plug, can not guarantee that whether there is some contact with the air, the results of the imaging laboratory tests after notifying the physician, the specimen was not analyzed, and a repeat blood collection was performed, which did not affect the patient's treatment and was understood by the patient's family.¿.

Event Description

It was reported that while using bd preset¿ arterial blood collection syringe, there was blood leakage as the blood went past the plunger stopper in the syringe.No patient impact reported.

Manufacturer Narrative

The following fields have been updated with corrected information.B.5.Describe event or problem: it was reported that while using bd preset¿ arterial blood collection syringe, there was blood leakage as the blood went past the plunger stopper in the syringe.No patient impact reported.H.6.Investigation summary: material #: 364314.Lot/batch #: 2272044.Bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and functional testing, each drawn with water, and no issues were observed relating to 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 leakage.Bd was not able to identify a root cause for the indicated failure mode.

• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 18076660
• MDR Text Key: 327436954
• Report Number: 9617032-2023-01591
• 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,Followup
• Report Date: 11/28/2023

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: 2272044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 11/27/2023
• Supplement Dates FDA Received: 12/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2022
• 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