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

Catalog Number 364314

Device Problem Defective Device (2588)

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

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured, bd corporate headquarters in (b)(4) has been listed for the manufacturing site.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

Event Description

It was reported when using the unspecified bd arterial blood gas syringe, the device experienced a deformed rubber stopper.The following information was provided by the initial reporter.The customer stated: (b)(6) 2022, the nurse gave 2 beds according to the doctor's advice.When arterial blood gas analysis was performed, the piston defect of arterial blood collector was found.The arterial blood collector was replaced immediately and the arterial blood specimen was collected and reported to the head nurse.

Manufacturer Narrative

The following fields have been updated due to additional information provided: site legal: becton, dickinson and company (bd) plymouth.B.5: describe event or problem: it was reported when using the bd preset¿ arterial blood collection syringe, the device experienced a deformed rubber stopper.The following information was provided by the initial reporter.The customer stated: 2022.9.15, the nurse gave 2 beds according to the doctor's advice.When arterial blood gas analysis was performed, the piston defect of arterial blood collector was found.The arterial blood collector was replaced immediately and the arterial blood specimen was collected and reported to the head nurse.D.1 medical device brand name: bd preset¿ arterial blood collection syringe.D.2 medical device type: jka.D.3 common device name: blood specimen collection device.D.4 medical device manufacturer: mfg gb plymouth.D.4 medical device catalog #: 364314.D.4.Medical device lot #: 2041496.D.4.Medical device expiration date: 2024-02-29.D.4 unique identifier: 50382903643146.G.4 manufacturing location: mfg gb plymouth.G.8 510k number: k022426.H.4.Device manufacture date: 2022-02-10.H.6 investigation summary: "material #: 364314.Lot/batch #: 2041496.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 damaged plunger stopper 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 damaged plunger stopper.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¿ arterial blood collection syringe, the device experienced a deformed rubber stopper.The following information was provided by the initial reporter.The customer stated: 2022.9.15, the nurse gave 2 beds according to the doctor's advice.When arterial blood gas analysis was performed, the piston defect of arterial blood collector was found.The arterial blood collector was replaced immediately and the arterial blood specimen was collected and reported to the head nurse.

• 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 NJ ; UK
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth NJ ; UK
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15575796
• MDR Text Key: 301838323
• Report Number: 2243072-2022-01750
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 364314
• Device Lot Number: 2041496
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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