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

Model Number	305764
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	04/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1274627.Medical device expiration date: 30-sep-2026.Device manufacture date: 01-oct-2021.Medical device lot #: 1238901.Medical device expiration date: 31-aug-2026.Device manufacture date: 26-aug-2021.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that one bd eclipse¿ needle each from lots 1274627 and 1238901 had black foreign matter on them.The following information was provided by the initial reporter: "there were black specs in the needles.".
Event or Problem Description
It was reported that one bd eclipse¿ needle each from lots 1274627 and 1238901 had black foreign matter on them.The following information was provided by the initial reporter: "there were black specs in the needles.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 25-apr-2022.H.6.Investigation: six photos and two samples were received by our quality team for evaluation.Photos 1-3 show an 18g eclipse product instead of 21g eclipse product, one black foreign matter was observed on the eclipse hub.Photos 4-6 show a 21g eclipse product whereby one black foreign matter was observed on the eclipse hub.The samples (one sample of batch 1238901 and one sample of batch 1274627) were subjected to visual inspection.The sample from batch 1238901 was observed to be built from mold l66, cavity 4 where there is one black embedded foreign matter on the eclipse hub.The sample from batch 1274627 was built from mold l58, cavity 2 where there is one black embedded foreign matter on the eclipse hub.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.There were no long stoppages of the molding machine during production.Any short stoppages of the molding machine will trigger an alarm and the production technician will perform manual purging to remove common defects like short molding.There was no heater change on the mold / press during production and there was also no unblock of the affected cavity before or during the production run.When the cavity is blocked, the cavity can overheat, and after unblocking the cavity, insufficient purging will result in embedded foreign matter.It is likely that the embedded foreign matter can be generated from the molding process due to a layer of carbonized material at the injection screw which starts to crack as the carbonized material becomes thicker which becomes black particles injected into the mold.The layer of carbonized material was generated from plastic remains in the plasticizing unit and starts to carbonize on the inner wall of the cylinder and on the screw surface.

• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14293320
• Report Number: 8041187-2022-00233
• Device Sequence Number: 20154340
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2022

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 Model Number: 305764
• Device Catalogue Number: 305764
• Device Lot Number: SEE SECTION H10
• 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: 04/11/2022
• Supplement Date Received by Manufacturer: 05/19/2022
• Initial Report FDA Received Date: 05/05/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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