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

Model Number	300255
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	04/09/2020
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.
Event or Problem Description
It was reported that hypoint ndl27ga1/2in punctured through the needle cap.This was discovered before use.The following information was provided by the initial reporter: received a complaint from the end user reporting issue the product neorecormon.Recormon 2000iu was prepared by a hcp to one of the dialysis patient prior 5 minutes of closing treatment.The hcp wanted to open the seal from the needle and she felt the pain sensation from her right index finger.Observed that the needle punctured through the needle cap.The hcp discarded the whole needle and take another needle gauge 25 as replacement.Iv recormon 2000iu was given to patient.This incident has caused an ae (needle prick injury to the hcp).
Additional Manufacturer Narrative
H.6.Investigation summary a device history review was conducted for lot number 9072973 for hypoint needle for bent needle no abnormalities noted.Based on the returned photos, able to confirm the customer experience.It seemed that the needle is piercing through the shield.The probable cause for needle piercing through the shield could be due to misalignment of the shield during the shield loading process and resulted the needle to pierce through at the shield press station.There is a shield height sensor which was installed to detect and reject units that may have misaligned shield.As this is the first occurrence in fy20, the complaint trend will be monitored.
Event or Problem Description
It was reported that hypoint ndl27ga1/2in punctured through the needle cap.This was discovered before use.The following information was provided by the initial reporter: received a complaint from the end user reporting issue the product neorecormon.Recormon 2000iu was prepared by a hcp to one of the dialysis patient prior 5 minutes of closing treatment.The hcp wanted to open the seal from the needle and she felt the pain sensation from her right index finger.Observed that the needle punctured through the needle cap.The hcp discarded the whole needle and take another needle gauge 25 as replacement.Iv recormon 2000iu was given to patient.This incident has caused an ae (needle prick injury to the hcp).

• Brand Name: HYPOINT NDL27GA1/2IN
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10031195
• Report Number: 8041187-2020-00243
• Device Sequence Number: 11388404
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 300255
• Device Catalogue Number: 300255
• Device Lot Number: 9072973
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 04/16/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 05/11/2020
• 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