MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD NEEDLE ECLIPSE S/T 21X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305895
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd needle eclipse s/t 21x1-1/2 rb tw had foreign matter.The following information was provided by the initial reporter: we¿ve recently come across a dirty cannula that was stored in one of our theatres before use.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 305895 and lot number 2411011.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, five (5) picture samples and the affected physical sample were returned for evaluation by our quality team.Unfortunately, the physical sample could not be located upon the noted delivery.A thorough analysis was completed using the pictures provided.If the physical sample is found, additional investigation findings may be updated.The picture samples show an eclipse needle with black spots.The black spots were identified as embedded contamination.The embedded particles could have been produced during the injection machine process.Due to the high working temperatures, different gases are produced inside of the molds.During normal production, these gases are expelled through conduits outside of the mold cavity.In this case, due to some unusual circumstance, the gases were not expelled correcting causing burnt pieces to occur within the mold cavity (the black spots).We would like to inform you that this is a cosmetic defect only with no health risk as the plastic pieces are embedded without the possibility of detachment.Based on the preventive measures in place, we believe the probability of this defect is very low with an unlikely chance of recurrence.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD NEEDLE ECLIPSE S/T 21X1-1/2 RB TW
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21351540
• Report Number: 3002682307-2025-00015
• Device Sequence Number: 21072750
• Product Code: FMI
• UDI-Device Identifier: 00382903058952
• UDI-Public: (01)00382903058952(11)241031(17)291031(10)2411011
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K100209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2025

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: 305895
• Device Lot Number: 2411011
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 04/18/2025
• Initial Report FDA Received Date: 02/10/2025
• Supplement Report FDA Received Date: 04/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/31/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown