MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE BLUNT FILL 18G X 1 1/2IN NS; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 305827

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

H.6 investigation summary: it was reported the needle came unscrewed and some medication leaked out.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a needle assembly with the plastic shield connected to a syringe.No other information could be obtained from the photo.As the lot provided is 'unknown,' a device history record review could not be completed.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.Without the physical sample analysis, a probable root cause could not be determined.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.D.4 device expiration date: unknown h.4.Device manufacture date: unknown h3 other text : see h.10.

Event Description

It was reported that the bd needle blunt fill 18g x 1 1/2in ns became loose causing leakage.The following information was provided by the initial reporter: while drawing up the patient¿s 16 vials of meds adapter needle came unscrewed on the last approx.0.1 ml of one syringe and leaked out.Very minimal leakage.Was able to tighten and continue using it, and the patient was informed of the same.P/n: bx305827, lot unknown, no sample available.

• Brand Name: BD NEEDLE BLUNT FILL 18G X 1 1/2IN NS
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17285245
• MDR Text Key: 318786363
• Report Number: 1911916-2023-00470
• Device Sequence Number: 1
• Product Code: FMI
• 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
• Report Date: 06/17/2023

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: 305827
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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