MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD SYRINGE 10ML SALINE XS; SALINE VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Short Fill (1575)

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

Event Date 10/19/2023

Event Type  malfunction  

Event Description

It was reported that bd syringe 10ml saline xs did not have the designated amount of saline.The following information was provided by the initial reporter: the customer states that, "visited patient for disconnection.Syringe removed out of packaging for flushing purposes.On removal, noticed syringe had only 6ml instead of stated 10ml on packaging".

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

No additional information.

Manufacturer Narrative

A device history record review was completed for provided material number 306572 and lot number 3089846.The review did not reveal any possible non-conformances during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, four (4) picture samples were received for evaluation by our quality team.The picture samples confirmed the defect of underfilled syringe.Although we were able to confirm the defect, an exact cause for the underfilled syringe could not be determined.If the physical sample becomes available, we would appreciate the opportunity to review it.This is the first report received for this type of issue on material (b)(4) and lot 3089846.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

Manufacturer Narrative

Correction made: we became aware on (b)(6) 2024 that the awareness date for this complaint was (b)(6) 2023.

• Brand Name: BD SYRINGE 10ML SALINE XS
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18361405
• MDR Text Key: 330983665
• Report Number: 9616657-2023-00056
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: UKN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 306572
• Device Lot Number: 3089846
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1