MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 18X1-1/2 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305766
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd needle eclipse 18x1-1/2 rb had foreign matter the following information was provided by the initial reporter: it was reported by the customer that the needle is covered 3/4 the way down with white plastic coating.Verbatim: rcc received a complaint via email.Email(s) attached.Issue: needle is covered 3/4 the way down with white plastic coating.Sample: sample kept in a container in the clinic.Photo: n/a.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.B3.The date received by manufacturer has been used for this field.
Additional Manufacturer Narrative
Batch number is unavailable and hence unable to perform the dhr review.Current control there is a visual inspection for foreign matter at the qa outgoing inspection and visual inspection for foreign matter at the assembly in-process inspection.As actual sample was not received for further investigation, actual root cause could not be determined.The complaint will be re-opened and re-investigated when sample is received.
Event or Problem Description
Material#: 305766 lot#: 00382903057665 it was reported by the customer that the needle is covered 3/4 the way down with white plastic coating.Verbatim: rcc received a complaint via email.Email(s) attached.Item: bd305766 -hmms item 117943 issue: needle is covered 3/4 the way down with white plastic coating.Lot #: 00382903057665 sample: sample kept in a container in the clinic photo: n/a.

• Brand Name: BD NEEDLE ECLIPSE 18X1-1/2 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18940675
• Report Number: 2243072-2024-00303
• Device Sequence Number: 19556821
• Product Code: FMI
• UDI-Device Identifier: 30382903057666
• UDI-Public: (01)30382903057666
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2024

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: Other
• Device Catalogue Number: 305766
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2024
• Supplement Date Received by Manufacturer: 04/23/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown