MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306546

Device Problem Failure to Deliver (2338)

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

Event Date 07/13/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.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 2 of the bd pre-filled saline syringe had difficulty expeling fluid.The following was received from the initial reporter: verbatim: i have since received two other syringes with different lot #¿s that are difficult to expel the fluid from the syringe.Response received 21 july 2023: was there any patient involvement for both lot numbers involved? i believe staff were trying to flush lines & only part of syringe fluid able to be injected easily.How was the patient outcome? are there any clinical signs, health consequences or impact? no issues other than potential concerns of iv placement issues.Any adverse event or serious injury reported to patient that has not been reported? if yes, please provide the details.None that i am aware.

Event Description

It was reported that 2 of the bd pre-filled saline syringe had difficulty expeling fluid.The following was received from the initial reporter: verbatim: i have since received two other syringes with different lot #¿s that are difficult to expel the fluid from the syringe.Response received 21 july 2023.Was there any patient involvement for both lot numbers involved? i believe staff were trying to flush lines & only part of syringe fluid able to be injected easily how was the patient outcome? are there any clinical signs, health consequences or impact? no issues other than potential concerns of iv placement issues.Any adverse event or serious injury reported to patient that has not been reported? if yes, please provide the details.None that i am aware.

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: 03-aug-2023.H.6.Investigation summary: it was reported it is difficult to expel the fluid from the syringe.To aid in the investigation, two empty samples with no packaging flow wraps or tip caps were received for evaluation by our quality team.One sample is for lot 3117553 and one sample is for lot 3079553.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then tested for sustaining force, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and all results were within specification.It could be possible that some units received were towards the higher end of specification requiring more force than normal to expel.A device history record review was completed for provided material number (b)(4), lots 3117553 and 3079553.The reviews did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for these lots.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be 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 PRE-FILLED SALINE 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 ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17438919
• MDR Text Key: 320222534
• Report Number: 1911916-2023-00537
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065463
• UDI-Public: (01)30382903065463
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161552
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/08/2023

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: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 3117553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2023
• Supplement Dates Manufacturer Received: 08/08/2023
• Supplement Dates FDA Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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