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

Catalog Number	300263
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 the hypoint ndl22ga1-1/2in tw experienced product damage with the device still operable.It is unknown whether the item defect was noted prior to, during, or after use.The following information was provided by the initial reporter: we inform you that we received a new complaint for a needle quality issue.Needle batch impacted 22g (hypoint ndl 22ga1-1/2in tw) 18050014 (supplier batch 8038451).
Additional Manufacturer Narrative
Investigation: dhr was reviewed and no notification was raised for this defect for the past 12 months.Since there are no samples and photos displaying the reported condition, the root cause could not be determined.The complaint is unconfirmed as no photo or samples were received.
Event or Problem Description
It was reported that the hypoint ndl22ga1-1/2in tw experienced product damage with the device still operable.It is unknown whether the item defect was noted prior to, during, or after use.The following information was provided by the initial reporter: we inform you that we received a new complaint for a needle quality issue.Needle batch impacted 22g (hypoint ndl 22ga1-1/2in tw) 18050014 (supplier batch 8038451).

• 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: 8748608
• Report Number: 8041187-2019-00500
• Device Sequence Number: 19432587
• Product Code: FMI
• UDI-Device Identifier: 00382903002634
• UDI-Public: 00382903002634
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2019

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: 02/28/2023
• Device Catalogue Number: 300263
• Device Lot Number: 8038451
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 07/15/2019
• 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