MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) INSYTE GRAY 16GA X 1.16IN; INTRAVASCULAR CATHETER

Model Number	381254
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 insyte gray 16ga x 1.16in package is open.The following information was provided by the initial reporter: the packaging is open.
Additional Manufacturer Narrative
Additional 1x information has been received that changes the reportability.Per the additional 1x information, the complaint is a duplicate of mfr report # 8041187-2018-00406 and is being canceled.
Event or Problem Description
It was reported that insyte gray 16ga x 1.16in package is open.The following information was provided by the initial reporter: the packaging is open.

• Brand Name: INSYTE GRAY 16GA X 1.16IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11285830
• Report Number: 8041187-2021-00075
• Device Sequence Number: 14323224
• Product Code: FOZ
• UDI-Device Identifier: 30382903812548
• UDI-Public: 30382903812548
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K151698
• 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): 02/17/2021

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: Other
• Device Expiration Date: 12/31/2019
• Device Model Number: 381254
• Device Catalogue Number: 381254
• Device Lot Number: 4351328
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1