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

Catalog Number	300255
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7051442.Medical device expiration date: 2022-02-28.Device manufacture date: 2017-03-09.Medical device lot #: 7051465.Medical device expiration date: 2022-02-28.Device manufacture date: 2017-03-15.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that bd hypoint¿ hypodermic needle had foreign matter inside of the needle hub.No serious injury or medical intervention was reported.
Additional Manufacturer Narrative
Investigation: dhr review has been performed and showed no abnormalities from the 3 processes (hypodermic hub, hypodermic needle and hypoint assembly).Returned samples and photos observed embedded fm.The reported non-conformance is likely to occur during molding process.
Event or Problem Description
It was reported that bd hypoint¿ hypodermic needle had foreign matter inside of the needle hub.No serious injury or medical intervention was reported.

• 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: 8336212
• Report Number: 8041187-2019-00144
• Device Sequence Number: 2034770
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2019

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 Catalogue Number: 300255
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 01/29/2019
• Initial Report FDA Received Date: 02/13/2019
• Supplement Report FDA Received Date: 03/08/2019
• 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