MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 27X1/2; 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	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 27x1/2 label content missing it was reported by the customer that the lot variable data on needle eclipse blister is missing, as required per amgen requirements.Verbatim: on (b)(6) 2024: during incoming inspection at iqa office of bd needle eclipse batch 0010759435, sr.Associate qa observed that the lot variable data on needle eclipse blister is missing, as required per amgen requirements.- 5 out of 315 sampled needle eclipse units were missing the lot variable data thus not according to specification requirements.Refer to attachment "tr# 586110, missing lot variable data".The acceptance and reject criteria for the assigned inspection profile: normal, aql (0.15) for the appearance was 1 and 2 respectively.Because the criteria were not met, the complete batch failed quality inspection.Impacted batch data vendor batch# 4029205.Amgen batch# 0010759435.Quantity: 30000 ea.Expected situation: the lot variable data of the bd needle eclipse units is expected to be present on each needle eclipse blister.
Additional Manufacturer Narrative
Our quality engineer inspected the photos submitted for evaluation.The reported issue of label content missing was confirmed upon inspection of the photos.Based on the received photo, a missing variable print was observed on the top web.The probable root cause could be the production technician not performing the line clearance before resuming production.This might have occurred during an operational stop due to a machine issue, which temporarily turned off the printer.Thus, the products flowed to the next process.To prevent this defect in the future, re-training of the packaging production technician will be conducted on the proper line purging procedure.One interview session per packaging production technician will be conducted to verify that the associates understand the need to perform the proper line purging.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 batch meets our manufacturing specification requirements.
Event or Problem Description
Materials#: 305758, batch#: 4029205.It was reported by the customer that the lot variable data on needle eclipse blister is missing, as required per amgen requirements.Verbatim: on (b)(6) 2024: during incoming inspection at iqa office of bd needle eclipse batch 0010759435, sr.Associate qa observed that the lot variable data on needle eclipse blister is missing, as required per amgen requirements.5 out of 315 sampled needle eclipse units were missing the lot variable data thus not according to specification requirements.Refer to attachment "tr# 586110, missing lot variable data".The acceptance and reject criteria for the assigned inspection profile: normal, aql (0.15) for the appearance was 1 and 2 respectively.Because the criteria were not met, the complete batch failed quality inspection.Impacted batch data vendor batch# 4029205, amgen batch# 0010759435, material# 3006813, quantity: 30000 ea.Expected situation: the lot variable data of the bd needle eclipse units is expected to be present on each needle eclipse blister.

• Brand Name: BD NEEDLE ECLIPSE 27X1/2
• 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: 19548468
• Report Number: 2243072-2024-00721
• Device Sequence Number: 4735024
• Product Code: FMI
• UDI-Device Identifier: 00382903057580
• UDI-Public: (01)00382903057580
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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: 305758
• Device Lot Number: 4029205
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 06/28/2024
• Initial Report FDA Received Date: 06/17/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/02/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown