MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 22GX1.00IN WINGED BC; CATHETER

Model Number	386813
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that cathena 22gx1.00in winged bc had difficult engaging the threads on the catheter.This was discovered during use.The following information was provided by the initial reporter: material no: 386813 batch no: unknown.It was reported that it is difficult to engage the threads on the catheter to flush catheter.Threading of luer lok poor design.User required to force end of flush into catheter to engage threads.Design should be - insert and thread, then spring engages after 15 degree rotation, instead of the necessity of depressing the spring initially.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified and the root cause could not be determined.A device history record could not be evaluated, as the lot number is unknown.Though an investigation by the manufacturing plant could not be done, sales and marketing did reach out to the customer.During the discussion, it was concluded that there was a lack of understanding of the new product due to lack of training provided.This is a result of covid-19 as they were not allowed to enter the hospital.
Event or Problem Description
It was reported that cathena 22gx1.00in winged bc had difficult engaging the threads on the catheter.This was discovered during use.The following information was provided by the initial reporter: material no: 386813 batch no: unknown.It was reported that it is difficult to engage the threads on the catheter to flush catheter.Threading of luer lok poor design.User required to force end of flush into catheter to engage threads.Design should be - insert and thread, then spring engages after 15 degree rotation, instead of the necessity of depressing the spring initially.

• Brand Name: CATHENA 22GX1.00IN WINGED BC
• Common Device Name: CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10107361
• Report Number: 8041187-2020-00301
• Device Sequence Number: 2309768
• Product Code: FPA
• UDI-Device Identifier: 00382903868131
• UDI-Public: 00382903868131
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/09/2020

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: Other
• Device Model Number: 386813
• Device Catalogue Number: 386813
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/11/2020
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 06/01/2020
• Supplement Report FDA Received Date: 07/09/2020
• 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