MAUDE Adverse Event Report: BECTON DICKINSON UNDISCLOSED BD PREFILLED SYRINGE; SALINE VASCULAR ACCESS FLUSH

Catalog Number UNKNOWN

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 02/11/2024

Event Type  malfunction  

Event Description

It was reported that bd undisclosed prefilled syringe cap fell off tip.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2024 at 23:15, (b)(6) nurse, sealing an indwelling needle at the end of an infusion for a patient on bed 40, (b)(6), male, 51 years old, hospital number (b)(6), with a fracture of the right wrist, found that the tapered head cap of the prefilled catheter flosser had fallen off and immediately replaced the prefilled catheter flosser to seal the needle for the patient.The adverse event did not result in harm to the patient.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.Bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.

Manufacturer Narrative

As no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.

Event Description

No additional information.

• Brand Name: UNDISCLOSED BD PREFILLED SYRINGE
• Type of Device: SALINE VASCULAR ACCESS FLUSH
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18889168
• MDR Text Key: 337488266
• Report Number: 2243072-2024-00277
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 04/17/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1