MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA¿ SAFETY IV CATHETER

Catalog Number	386801
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	02/07/2019
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.
Event or Problem Description
It was reported that during use of the bd cathena¿ safety iv catheter the 18g catheter had some flick at the end of withdrawal time, blood sprayed up on medic's arm.
Additional Manufacturer Narrative
H.6.Investigation summary: 1 photo received, an arm with spattered blood was shown in the photo.1 representative sample (unopened) was returned for investigation.A device history record review showed no non-conformances associated with this issue during the production of this batch.The sample are subjected to blood escape time (bet) test to check for adapter leakage.The returned sample passed the bet test, no leakage/spatter was observed.The complaint is not confirmed and product is within specification.1 video received for investigation.From the video, it was observed that the hub was tilted to the right and the cannula was bent during the activation.The action causes the shield flick after the activation.The flick was due to user error.The complaint is not confirmed as the photo received does not show the nonconforming product and no abnormality was observed on the representative sample.According to the video received, the flick after activation was due to user error.Qn history for past 12 months was reviewed, no similar qn raised.There was a capa raised for blood droplet formation at the luer end of the catheter adapter.Small id catheter tubing and small septum vents have been implemented to address the issue.
Event or Problem Description
It was reported that during use of the bd cathena¿ safety iv catheter the 18g catheter had some flick at the end of withdrawal time, blood sprayed up on medic's arm.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8381891
• Report Number: 8041187-2019-00179
• Device Sequence Number: 1341290
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 00382903868018
• 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): 04/12/2019

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: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: 386801
• Device Lot Number: 8060125
• Initial Date Received by Manufacturer: 02/08/2019
• Supplement Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/12/2019
• 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