MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	386804
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
Event or Problem Description
It was reported that an unspecified number of bd cathena¿ safety iv catheters experienced leakage.The following information was provided by the initial reporter: material no: 386804, batch no: unknown.Ct manager sent email expressing they are experiencing frequent contrast extravasation events in ct dept.For the most part using 18g for high flow rate injections, test iv's prior to being hooked up to pump.Some ct units are also using 20g for all their injections.Questions/inquiries: what is the date(s) of the event? how many affected items were involved? where was the leakage? do you have samples available that can be sent for evaluation, and if so are those contaminated? if you are unable to send a sample, can a photo be provided? what kind of medication was drawn for injection with the affected items? customer response there were several dates of events.I would say i get 1 or 2 extravasation reports per week.They events typically occur towards the end of the injections.Not sure what you mean by how many affected items were involved.No, there is no leakage.The vein seems to collapse and the remaining contrast/saline begins to go into the interstitium.Course of treatment depends on the amount of extravasation.Typically the patient is monitored.The radiologist is consulted.A compress is applied.The patient is instructed to keep their arm over their head, etc.Patient involvement? if you mean for after care, yes.The patient is always counselled.What types of sample are you looking for? we don¿t take photos of patients.The medication is always omnipaque 350, a contrast agent used for ct scans.
Event or Problem Description
It was reported that an unspecified number of bd cathena¿ safety iv catheters experienced leakage.The following information was provided by the initial reporter: material no: 386804; batch no: unknown.Ct manager sent email expressing they are experiencing frequent contrast extravasation events in ct dept.For the most part using 18g for high flow rate injections, test iv's prior to being hooked up to pump.Some ct units are also using 20g for all their injections.Questions/inquiries: what is the date(s) of the event? how many affected items were involved? where was the leakage? do you have samples available that can be sent for evaluation, and if so are those contaminated? if you are unable to send a sample, can a photo be provided? what kind of medication was drawn for injection with the affected items? customer response there were several dates of events.I would say i get 1 or 2 extravasation reports per week.They events typically occur towards the end of the injections.Not sure what you mean by how many affected items were involved.No, there is no leakage.The vein seems to collapse and the remaining contrast/saline begins to go into the interstitium.Course of treatment depends on the amount of extravasation.Typically the patient is monitored.The radiologist is consulted.A compress is applied.The patient is instructed to keep their arm over their head, etc.Patient involvement? if you mean for after care, yes.The patient is always counselled.What types of sample are you looking for? we don¿t take photos of patients.The medication is always omnipaque 350, a contrast agent used for ct scans.
Additional Manufacturer Narrative
H6: investigation summary: 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.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10668512
• Report Number: 8041187-2020-00666
• Device Sequence Number: 3485921
• Product Code: FOZ
• UDI-Device Identifier: 00382903868049
• UDI-Public: 00382903868049
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K201717
• 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): 12/17/2020

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: 386804
• Device Catalogue Number: 386804
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 10/13/2020
• Supplement Report FDA Received Date: 12/29/2020
• 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