MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿ HYPODERMIC NEEDLE

Catalog Number	300255
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2018
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 #: 5287055, device manufacture date: 2016-01-08.Medical device lot #: 5301458, device manufacture date: 2016-01-26.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 before use of the bd hypoint¿ hypodermic needle the "health worker found one threadlike foreign matter inside of the needle shield when he removed the lid label.He also found one fiber on the hub." there was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: no sample was returned to bd for investigation, but a photo was received showing the reported defect.One shiny, loose, thread-like fm and one fiber-like fm was observed in the photo received.A review of the device history record revealed no irregularities during the manufacture of the reported lots.Investigation conclusion: there is no returned sample for ftir analysis to understand the fm source.The size of the fm could not be determine.Hence, root cause cannot be established.

• Brand Name: BD HYPOINT¿ HYPODERMIC NEEDLE
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7283893
• Report Number: 8041187-2018-00036
• Device Sequence Number: 1109999
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K070440
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2018

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: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: 300255
• Device Lot Number: SEE H.10.
• Initial Date Received by Manufacturer: 02/05/2018
• Supplement Date Received by Manufacturer: 02/05/2018
• Initial Report FDA Received Date: 02/20/2018
• Supplement Report FDA Received Date: 03/12/2018
• 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