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 Patient Involvement (2645)
Date of Event	06/17/2020
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.
Event or Problem Description
It was reported that cathena 22gx1.00in winged bc blood control safety feature failed.This was discovered during use.The following information was provided by the initial reporter: material no: 386813 batch no: 8116294.It was reported that blood control safety failed on practice wet arm the customer reports this has been occurring with patient insertions.Questions/inquiries: photos of scenario and/or failed product? i do not have pictures at this time.It is likely that we can reproduce the issue if you request it.Can you describe the failure? is it failing at the cathena catheter or from the guard below the wings? even with appropriate iv insertion technique, we will have blood return from the end of the catheter where we would attach the iv tubing.The blood penetrates beyond the blood control mechanism.This was produced on a ¿wet arm¿ where there was only moderate pressure and no actual living blood pressure.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 2020-07-17.H.6.Investigation summary two samples were received by our quality team for evaluation.These samples were subjected to the blood escape time test and both samples passed with no abnormalities observed.Therefore, the investigation was not able to confirm the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.
Event or Problem Description
It was reported that cathena 22gx1.00in winged bc blood control safety feature failed.This was discovered during use.The following information was provided by the initial reporter: material no: 386813 batch no: 8116294 it was reported that blood control safety failed on practice wet arm the customer reports this has been occurring with patient insertions.Questions/inquiries: photos of scenario and/or failed product? i do not have pictures at this time.It is likely that we can reproduce the issue if you request it.Can you describe the failure? is it failing at the cathena catheter or from the guard below the wings? even with appropriate iv insertion technique, we will have blood return from the end of the catheter where we would attach the iv tubing.The blood penetrates beyond the blood control mechanism.This was produced on a ¿wet arm¿ where there was only moderate pressure and no actual living blood pressure.

• 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: 10242681
• Report Number: 8041187-2020-00386
• Device Sequence Number: 11514322
• 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): 07/30/2020

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 Expiration Date: 04/30/2021
• Device Model Number: 386813
• Device Catalogue Number: 386813
• Device Lot Number: 8116294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 06/17/2020
• Initial Report FDA Received Date: 07/07/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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