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	12/20/2017
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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 6348374, device manufacture date: 2017-01-14.Medical device lot #: 6348375, device manufacture date: 2017-01-24.
Event or Problem Description
It was reported before use of the bd hypoint¿ hypodermic needle the health care worker found foreign matter on the needles before injection.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation results: one sample was returned.The loose thread-like fm in the first photo was not observed.One loose white thread-like fm and gel-like fm were observed.Sizes of the fm are measured and found to be less than 0.05mm2.The smallest rejected fm size is from 0.05mm2.Hence, the fm size is within specification.Dhr review was performed.Hypoint batch (6348374/6348375) hypodermic needle (6333382/6362409) hypoint shield (3635108/3635112/6333163) hypodermic hub (6363457/6365103) no similar defect was found in the in process and out going inspections.No notification was raised for this defect.No capa is required as product is within specification.

• 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: 7244825
• Report Number: 8041187-2018-00013
• Device Sequence Number: 2248882
• 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): 02/19/2018

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: Other
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: 300255
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Initial Date Received by Manufacturer: 01/16/2018
• Supplement Date Received by Manufacturer: 01/16/2018
• Initial Report FDA Received Date: 02/06/2018
• Supplement Report FDA Received Date: 02/20/2018
• 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