MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) HYPOINT NDL22GA1-1/2IN TW; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	300263
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9155553, medical device expiration date: 2024-06-30, device manufacture date: 2019-07-22, medical device lot #: 9009925, medical device expiration date: 2024-01-31, device manufacture date: 2019-02-19.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 ndl22ga1-1/2in tw needle was loose.This was discovered before use.The following information was provided by the initial reporter: the rapporteur reported that during the preparation of the product, when injecting the diluent in the bottle, the needle came loose and part of the diluent was wasted.The needle was well fitted by her, as she is already used to the procedure.
Additional Manufacturer Narrative
H6: investigation summary no product or photo was returned by the customer.The customer complaint could not be verified due to the product not being returned for failure investigation.Based on the dhr review, there is no abnormality that may influenced luer taper.H3 other text : see h.10.
Event or Problem Description
It was reported that hypoint ndl22ga1-1/2in tw needle was loose.This was discovered before use.The following information was provided by the initial reporter: the rapporteur reported that during the preparation of the product, when injecting the diluent in the bottle, the needle came loose and part of the diluent was wasted.The needle was well fitted by her, as she is already used to the procedure.

• Brand Name: HYPOINT NDL22GA1-1/2IN TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10714631
• Report Number: 8041187-2020-00684
• Device Sequence Number: 16940137
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 11/04/2020

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 Model Number: 300263
• Device Catalogue Number: 300263
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/04/2020
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1