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

Model Number	300263
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2020
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 #: 9155552.Medical device expiration date: 2024-06-30.Device manufacture date: 2019-07-22.Medical device lot #: 9287090.Medical device expiration date: 2024-10-31.Device manufacture date: 2019-11-20.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 leaked.The following information was provided by the initial reporter: we inform you that we have received a new complaint for a needle quality issue (¿the pharmacist informed that he had already been in contact because the client went to make the needle bigger and there was a leak of the product¿).Update : bigger needle (needle 22g) used for the preparation of the reconstituted solution ¿ little needle (needle 30g) used only for the injection of the reconstituted solution.
Additional Manufacturer Narrative
Investigation summary: no samples or photos were returned for investigation.Hence, no root cause is established.Based on dhr review, there is no abnormality that may influenced this non-conformance.
Event or Problem Description
It was reported that hypoint ndl22ga1-1/2in tw leaked.The following information was provided by the initial reporter: we inform you that we have received a new complaint for a needle quality issue (¿the pharmacist informed that he had already been in contact because the client went to make the needle bigger and there was a leak of the product¿).Update : bigger needle (needle 22g) used for the preparation of the reconstituted solution ¿ little needle (needle 30g) used only for the injection of the reconstituted solution.

• Brand Name: HYPOINT NDL22GA1-1/2IN TW
• Common Device Name: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11340777
• Report Number: 8041187-2021-00104
• Device Sequence Number: 10983742
• 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
• Serviced by Third Party (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): 03/05/2021

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: 01/25/2021
• Supplement Date Received by Manufacturer: 03/05/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1