MAUDE Adverse Event Report: UNSPECIFIED BD 20 G CATHENA CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Retraction Problem (1536)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.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.

Event Description

It was reported that the unspecified bd 20 g cathena catheter experienced difficult safety mechanism disengagement.The following information was provided by the initial reporter: both nurses had a similar adverse event that they did not declare: when the mandrin was removed, the safety device (white box) remained on the base and released the mandrin (risk of major exposure to blood).Dr wanted to make a declaration but the device and the packaging were thrown away before he could do so he remembered that it was a kt 20g the nurse did not remember the reference.Two cardiology nurses each placed a peripheral venous catheter (bd cathena).Afterwards, they wanted to take a blood sample but no blood was returned.However, when she connected the infusion set, the infusion went through.Confirm if there were any consequences for the patient or medical staff? -yes, there were consequences.For the patient: he had to go through another sampling for a blood test.For the nurse: loss of time and additional handling.

Event Description

It was reported that the unspecified bd 20 g cathena catheter experienced difficult safety mechanism disengagement.The following information was provided by the initial reporter: both nurses had a similar adverse event that they did not declare: when the mandrin was removed, the safety device (white box) remained on the base and released the mandrin (risk of major exposure to blood).Dr wanted to make a declaration but the device and the packaging were thrown away before he could do so he remembered that it was a kt 20g the nurse did not remember the reference.Two cardiology nurses each placed a peripheral venous catheter (bd cathena).Afterwards, they wanted to take a blood sample but no blood was returned.However, when she connected the infusion set, the infusion went through.- confirm if there were any consequences for the patient or medical staff? -yes, there were consequences.For the patient: he had to go through another sampling for a blood test.For the nurse: loss of time and additional handling.

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.H3 other text : see h10.

• Brand Name: UNSPECIFIED BD 20 G CATHENA CATHETER
• Type of Device: INTERVASCULAR CATHETER
• MDR Report Key: 12453957
• MDR Text Key: 271517776
• Report Number: 2243072-2021-02291
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1