MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD POSIFLUSH¿ SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306594

Device Problem Defective Component (2292)

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

Event Date 07/24/2023

Event Type  malfunction  

Event Description

It was reported that 5 bd posiflush¿ syringe' barrels were found damaged when removing them from the box packaging.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from chinese: "customers from the box out ready to inject when the front end of the syringe deformation, can not be pushed injection, and this has happened several times in the past, so reported to the hospital spd equipment section, immediately contacted the agent, doubt whether it is the production of irregularities caused by why many times this kind of problem occurs, reported to the hospital consumables adverse events.(b)(6) 2023 the nurse opened the seal in preparation for sealing the child's tube and found that the plasticity was faulty, not used, and replaced with a new product.".

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 5 bd posiflush¿ syringe' barrels were found damaged when removing them from the box packaging.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from chinese: "customers from the box out ready to inject when the front end of the syringe deformation, can not be pushed injection, and this has happened several times in the past, so reported to the hospital spd equipment section, immediately contacted the agent, doubt whether it is the production of irregularities caused by why many times this kind of problem occurs, reported to the hospital consumables adverse events.2023.7.1 the nurse opened the seal in preparation for sealing the child's tube and found that the plasticity was faulty, not used, and replaced with a new product.".

Manufacturer Narrative

The following fields have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 10-aug-2023.H.6.Investigation summary: it was reported the front end of the syringe deformed.To aid in the investigation, one sample with no packaging flow wrap and three photos were provided for evaluation by our quality team.A visual inspection was performed and the syringe barrel luer is bent.The three photos provided show the sample received.No other defects or imperfections were observed.This defect could occur if the unit was not correctly placed in the sterilizing fixture.A device history record review was completed for provided material number (b)(4), lot 2087541.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.The sample will be shown to associates for awareness.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD POSIFLUSH¿ SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17484881
• MDR Text Key: 321106012
• Report Number: 1911916-2023-00565
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 09/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306594
• Device Lot Number: 2087541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/28/2022
• 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