MAUDE Adverse Event Report: BECTON DICKINSON UNKNOWN BD NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	381244
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Opened and found that the tip of the needle has a rubbery foreign body, unused.
Event or Problem Description
Opened and found that the tip of the needle has a rubbery foreign body, unused.
Additional Manufacturer Narrative
Our quality engineer inspected the 2 samples submitted for evaluation.The reported issue of silicone visible was confirmed upon inspection of the samples.Analysis of the samples showed a small droplet of transparent, gel-like substance on the cannula on one sample.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this lot meets our manufacturing specification requirements.The small droplet of transparent, gel-like substance observed at the cannula tip in the returned sample, is most likely the catheter lubricant.The lubricant appearance was found to be acceptable per bd tuas test procedure.As part of the manufacturing process, lubricant is applied onto the outer surface of the catheter tubing to aid threading during needle insertion.As current control, there is an outgoing visual inspection in place to check for excessive lubricant on catheter.

• Brand Name: UNKNOWN BD NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore IL 60061
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19905239
• Report Number: 2243072-2024-00852
• Device Sequence Number: 18297421
• Product Code: FOZ
• UDI-Device Identifier: 00382903812448
• UDI-Public: (01)00382903812448(11)231020(17)280930(10)3293950
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 381244
• Device Lot Number: 3293950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/05/2024
• Supplement Report FDA Received Date: 09/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown