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

Model Number	300263
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: 1 returned sample was received.Returned sample observed broken needle and hypoint shield was broken.One returned photo was observed.Broken hypoint shield observed.Broken needle.Investigation conclusion: one returned sample was received for investigation and observed broken needle.One returned photo was received.Hence, able to confirm the customer experience.As per p-eura document, srd-rm0038, the severity is negligible(s1) as the product was found defective prior to initial use.Produced quantity: (b)(4).Occurrence is remote (o2).The risk level is determined to be low per cpr-028.Root cause description: dhr reviewed for affected batch numbers for hypoint needle, hypodermic needle, cannula do not observe abnormalities related to broken needle.Returned sample received observed broken needle.The process has been reviewed for hypoint needle, hypodermic needle, cannula which will not result in the reported non-conformance.From the returned sample, broken hypoint shield was observed and suspect there may be handling issues with the hypoint needle which may influence the reported non-conformance.Hence, root cause could not be established as the reported non-conformance maybe out of manufacturing facility.Rationale: root cause could not be established.
Event or Problem Description
It was reported that hypoint ndl22ga1-1/2in tw had a broken needle.This was discovered before use.The following information was provided by the initial reporter: needle was found broken before using.

• 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: 10018120
• Report Number: 8041187-2020-00236
• Device Sequence Number: 16890600
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: NA
• 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
• Report Date (Section B): 04/13/2020

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: Lay User/Patient
• Device Expiration Date: 05/31/2024
• Device Model Number: 300263
• Device Catalogue Number: 300263
• Device Lot Number: 9135938
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2020
• Initial Report FDA Received Date: 05/01/2020
• 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