MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL27GA1/2IN; NEEDLE

Model Number	300255
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that hypoint ndl 27 ga 1/2 in needle was broken.The following information was provided by the initial reporter: we would like to inform you regarding a complaint from an end user stating that the needle is broken and the front part is inside the cap.
Event or Problem Description
It was reported that hypoint ndl27ga1/2in needle was broken.The following information was provided by the initial reporter: we would like to inform you regarding a complaint from an end user stating that the needle is broken and the front part is inside the cap.
Additional Manufacturer Narrative
H.6.Investigation: no sample was returned for investigation.1 returned photo was received and there is needle observed in the hypoint shield.From the photo, the hypoint needle has been attached on the syringe and the hypoint shield has been removed with cannula observed in the shield.Based on the photo evaluation, it is unsure how the needle is broken.Understand from customer that it is unsure whether the broken needle is observed before or after use.Based on dhr review, there is no abnormality observed that may influenced broken needle.Based on hypoint process, the likely cause is from shield loading station and shield press station which have contact with the cannula.However, there is no broken needle observed for the past 2 years.In addition, it is unsure whether the broken needle happened before or after user used.Hence, the root cause is not established h3 other text : see h.10.

• Brand Name: HYPOINT NDL27GA1/2IN
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10512504
• Report Number: 8041187-2020-00549
• Device Sequence Number: 14210093
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2020

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: 05/31/2024
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 9135942
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/20/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/09/2020
• Supplement Report FDA Received Date: 09/18/2020
• 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