MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305781
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 foreign matter occurred before use with a syringe 3ml ll w/ndl eclipse 25x5/8 rb.The following information was provided by the initial reporter, "the eclipse needle had black spots when opened.Good afternoon all, i recently discovered a needle that is not sterile at my clinic.I opened the needle to give a influenza vaccines and saw black spots over the opening and inside the opening.Lot number is 9114863 and the expiration date 4/30/24.I am unsure of any other sites have had this concerns but wanted to let you guys know.".
Event or Problem Description
It was reported that foreign matter occurred before use with a syringe 3ml ll w/ndl eclipse 25x5/8 rb.The following information was provided by the initial reporter, "the eclipse needle had black spots when opened.Good afternoon all, i recently discovered a needle that is not sterile at my clinic.I opened the needle to give a influenza vaccines and saw black spots over the opening and inside the opening.Lot number is 9114863 and the expiration date 4/30/24.I am unsure of any other sites have had this concerns but wanted to let you guys know.".
Additional Manufacturer Narrative
Investigation: three photos and one actual sample were received by our quality team for evaluation.Upon visual inspection it was observed that there was black foreign matter embedded on the eclipse hub.A device history record review found no non-conformances associated with this issue during production of this batch.The black foreign matter was sent for ftir testing to determine what it was.The ftir results indicate that there is no good match available in the library; however, the spectrum of the embedded foreign matter showed some peaks that were similar to that of polypropylene, the base material of the hub sample.Based on the investigation the probable root cause of the embedded foreign matter could be a result of degraded polypropylene in the injection screw of the molding machine which makes the hub.Maintenance is done on the machine and it was communicated to the associates of the defect.

• Brand Name: SYRINGE 3ML LL W/NDL ECLIPSE 25X5/8 RB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9371730
• Report Number: 8041187-2019-00950
• Device Sequence Number: 3175023
• Product Code: FMI
• UDI-Device Identifier: 30382903057819
• UDI-Public: 30382903057819
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (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): 12/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 305781
• Device Lot Number: 9114863
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other