MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD PRE-FILLED SALINE SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Catalog Number 306572

Device Problem Missing Information (4053)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

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 2 of the bd pre-filled saline syringe scale marking was missing.The following was received by the initial reporter: issue: no labeling/gradation marking on syringe ¿ syringe completely blank patient harm: no.

Event Description

It was reported that 2 of the bd pre-filled saline syringe scale marking was missing.The following was received by the initial reporter: issue: no labeling/gradation marking on syringe ¿ syringe completely blank patient harm: no.

Manufacturer Narrative

He following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 21-sep-2023.Investigation summary: to aid in the investigation of this issue, two (2) syringe samples were returned for evaluation by our quality team.Through examination of the samples, the syringes were missing their barrel labels.A device history record review was completed for provided material number 306572 and lot number 3131602.The review did reveal one possible non-conformance during the production process that could have potentially contributed to this incident.During the manufacturing of lot number 313602, the plunger rod label applicator was intermittently not firing.This would have resulted in missing labels on the syringe barrels.These syringes went undetected by the vision system and were not properly rejected.An additional manufacturing control has been opened for the installation of a sensor further downstream to inspect all product for barrel label presence.

• Brand Name: BD PRE-FILLED SALINE SYRINGE
• 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: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17831105
• MDR Text Key: 324435074
• Report Number: 9616657-2023-00041
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 00382903065721
• UDI-Public: (01)00382903065721
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10/09/2023

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: 306572
• Device Lot Number: 3131602
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 09/28/2023
• Supplement Dates Manufacturer Received: 10/09/2023
• Supplement Dates FDA Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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