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

Catalog Number	386813
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	05/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of event: unknown.The date received by manufacturer has been used for this field.
Event or Problem Description
It was reported that damage occurred with a cathena 22gx1.00in winged bc.The following information was provided by the initial reporter: "we are continuing to have issues with catheters disconnecting and having to be replaced when they clot.We are currently using lot 8116294, and i've had several complaints related to this particular lot.We are noticing that the catheter stylets seem to be very dull, and it is requiring multiple attempts to place a catheter.In some cases it has required multiple limbs and multiple technicians, and they have still not been successful with cathena, but get it in instantly with an insyte.The 22g x 1" seem to be the major issue but are also the ones we are using with most regularity.".
Event or Problem Description
It was reported that damage occurred with a cathena 22gx1.00in winged bc.The following information was provided by the initial reporter, "we are continuing to have issues with catheters disconnecting and having to be replaced when they clot.We are currently using lot 8116294, and i've had several complaints related to this particular lot.We are noticing that the catheter stylets seem to be very dull, and it is requiring multiple attempts to place a catheter.In some cases it has required multiple limbs and multiple technicians, and they have still not been successful with cathena, but get it in instantly with an insyte.The 22g x 1" seem to be the major issue but are also the ones we are using with most regularity.".
Additional Manufacturer Narrative
Investigation summary: a device history record review was performed and showed no non-conformance's associated with this issue during the production of this batch.Since no samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.A review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance.

• Brand Name: CATHENA 22GX1.00IN WINGED BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8692937
• Report Number: 8041187-2019-00447
• Device Sequence Number: 2566764
• Product Code: FOZ
• UDI-Device Identifier: 00382903868131
• UDI-Public: 00382903868131
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2019

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: 04/30/2021
• Device Catalogue Number: 386813
• Device Lot Number: 8116294
• Initial Date Received by Manufacturer: 05/23/2019
• Supplement Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 06/19/2019
• 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