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

Catalog Number 306593

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that the bd pre-filled saline syringe experienced molding defect.The following information was provided by the initial reporter, translated from japanese to english: after the patient was given infusion, the catheter was flushed.After opening the package, it was found that the needle handle of the catheter was damaged and the edge had sharp scratches.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6).H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Pr 8989247: this is a correction to the initial mdr.The initial mdr was submitted in error due to the incorrect event type being reported.The event type has been corrected and this complaint has been deemed not reportable.If additional information is received to reverse that decision, another follow up will be submitted.H3 other text : see h10 manufacture narrative.

Event Description

No additional information after the patient was given infusion, the catheter was flushed.After opening the package, it was found that the needle handle of the catheter was damaged and the edge had sharp scratches.The flushing catheter was replaced.

• 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: 17916626
• MDR Text Key: 325842894
• Report Number: 1911916-2023-00761
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065937
• UDI-Public: (01)30382903065937
• 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: 10/12/2023

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: 306593
• Device Lot Number: 2040368
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2022
• 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