MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD HYPOINT¿ NDL27GA1/2IN; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	300255
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone #: unknown.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 that prior to use the needle shield was discovered to be broken and needle was exposed thus affecting sterility with a bd hypoint¿ ndl27ga1/2in.The following information was provided by the initial reporter: defect found, its needle container was broken before use.
Additional Manufacturer Narrative
H.6.Investigation summary: from the returned photo the hypoint shield was observed to be broken.Dhr reviewed for affected batch number and do not observe abnormalities.Based on returned photo the hypoint shield was broken before use as explained in the verbatim.Based on process fmea, there is a leakage test station to test for leakage of shield.The broken shield from the returned photo would have rejected at this station.Hence, the defect may be produced out of manufacturing facility.The root cause could not be established as the defect maybe produced out of manufacturing facility.
Event or Problem Description
It was reported that prior to use the needle shield was discovered to be broken and needle was exposed thus affecting sterility with a bd hypoint¿ ndl27ga1/2in.The following information was provided by the initial reporter: defect found, its needle container was broken before use.

• Brand Name: BD HYPOINT¿ NDL27GA1/2IN
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9774248
• Report Number: 8041187-2020-00112
• Device Sequence Number: 10902872
• Product Code: FMI
• UDI-Device Identifier: 00382903002559
• UDI-Public: 00382903002559
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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): 03/20/2020

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 300255
• Device Lot Number: 8136202
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 03/02/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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