MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	8975
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of pen ndl 31g 5mm 90 count mail order only experienced foreign matter contamination, which was noted during use.The following information was provided by the initial reporter: consumer reported upon removing the tear drop label from one pen needle, there is something small and red that he can see in the needle hub.Stated it almost looks like a bug.Lot #: 9114904.Catalog#: 320882.Date of event: (b)(6) 2020.
Event or Problem Description
It was reported that an unspecified number of pen ndl 31g 5mm 90 count mail order only experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: consumer reported upon removing the tear drop label from one pen needle, there is something small and red that he can see in the needle hub.Stated it almost looks like a bug.Lot #: 9114904.Catalog#: 320882.Date of event: 08/30/20.
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) open 5mm, 31g pen needle from lot # 9114904.Customer states that there is something small and red that the consumer can see in the needle hub.The returned pen needle was examined and exhibited reddish material on the inner surface of the outer cover.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely blood mixed with silicone.The blood would most likely not be acquired during the manufacturing site.Based on dhr review, no foreign matter was detected during the production of the reported batch.Root cause cannot be determined at this time as the issue is unconfirmed.The blood would most likely not be acquired during the manufacturing site.

• Brand Name: PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10564984
• Report Number: 8041187-2020-00597
• Device Sequence Number: 11067396
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2020

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: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: 8975
• Device Catalogue Number: 320882
• Device Lot Number: 9114904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 10/22/2020
• 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