MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ECLIPSE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305758
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd eclipse¿ needle the label was missing information.This occurred on 64800 pieces.There was no report of patient impact.The following information was provided by the initial reporter: (b)(6) has informed me that during the appearance inspection of the eclipse needles batch 0010716410, vendor lot 3083420 received last week.It was notified that the title on the blister was printed on the perforation.Which means that when the packs get separated, some of the text is missing/unreadable.It was found around 20 packs from one box with this issue.
Additional Manufacturer Narrative
B.3.Date of event is unknown; awareness date has been used for this field.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
Our quality engineer inspected the 1 photo submitted for evaluation.The reported issue of label content incorrect was confirmed upon inspection of the sample photo.Analysis of the sample photo showed that the top web artwork related to the bd eclipse brand name was cut off.The cannula gauge and size information were on the label, as well as the variable print information.Bd determined that the cause of the failure was related to our manufacturing process.Actions have been taken to address this issue.Production records were reviewed, and this batch meets our manufacturing specification requirements.H3 other text : see h10.
Event or Problem Description
It was reported while using bd eclipse¿ needle the label was missing information.This occurred on 64800 pieces.There was no report of patient impact.The following information was provided by the initial reporter: amgen breda has informed me that during the appearance inspection of the eclipse needles batch 0010716410, vendor lot 3083420 received last week.It was notified that the title on the blister was printed on the perforation.Which means that when the packs get separated, some of the text is missing/unreadable.It was found around 20 packs from one box with this issue.

• Brand Name: BD ECLIPSE¿ NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17738524
• Report Number: 8041187-2023-00487
• Device Sequence Number: 17861594
• Product Code: FMI
• UDI-Device Identifier: 30382903057581
• UDI-Public: (01)30382903057581
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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
• Operator of Device: Other
• Device Catalogue Number: 305758
• Device Lot Number: 3083420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown