MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL CAP DISINFECTION SINGLES CE; CAP DISINFECTOR

Catalog Number 306598

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that an unspecified number of cap disinfection singles ce experienced product damage/deformation with the device still considered operable which was noted during use.The product defect resulted in a serious injury in the form of a delay in treatment.When the product defect was noted, the patient was about to have a cardiac arrest.The product damage delayed the application of medication to the patient as the physician took time to investigate the issue, and find an alternative way to provide the treatment.No harm came to the patient as a result of the delay.The following information was provided by the initial reporter: our icu uses the product ¿pure hub disinfection cap (charge 9039512)¿.It was used today with a patient that was about to have a cardiac arrest, the cap was used to disinfect the 3-way-stopcock.After that, a highly effective emergency medication was supposed to be injected in order to prevent the cardiac arrest, but the alcohol pad inside the disinfection cap separated itself from the cap and entered the 3-way-stopcock.Given the 3-way-stopcock was blocked because of the alcohol pad, the patient did not receive the medication as fast as necessary.Because of this incident, we had to spend time investigating the reason why the 3-way-stopcock was blocked, which lead to a situation that put the life of the patient in danger.I would like you to investigate the incident.Luckily, the patient did not suffer any harm, but i would like you to investigate this incident to avoid incidents like this in the future.It is the second time we experience this problem in his month.For the moment, all disinfection caps are blocked from use.Furthermore, my colleague and i noticed that the quality of the caps is bad.The alcohol pad is often out of place and no longer centrally located after use.The position of the pad cannot be corrected after attaching and detaching the cap several times.

Manufacturer Narrative

Investigation: one sample was received.It came in a sealed biohazard plastic bag.It came with the three- way stopcock.It is contaminated.No further analysis was performed.This product is for one time used.It should be disposed after using it.The complaint states that this issue is induced by attaching and detaching it several times.A device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.

Event Description

It was reported that an unspecified number of cap disinfection singles ce experienced product damage/deformation with the device still considered operable which was noted during use.The product defect resulted in a serious injury in the form of a delay in treatment.When the product defect was noted, the patient was about to have a cardiac arrest.The product damage delayed the application of medication to the patient as the physician took time to investigate the issue, and find an alternative way to provide the treatment.No harm came to the patient as a result of the delay.The following information was provided by the initial reporter: our icu uses the product ¿pure hub disinfection cap (charge 9039512)¿.It was used today with a patient that was about to have a cardiac arrest, the cap was used to disinfect the 3-way-stopcock.After that, a highly effective emergency medication was supposed to be injected in order to prevent the cardiac arrest, but the alcohol pad inside the disinfection cap separated itself from the cap and entered the 3-way-stopcock.Given the 3-way-stopcock was blocked because of the alcohol pad, the patient did not receive the medication as fast as necessary.Because of this incident, we had to spend time investigating the reason why the 3-way-stopcock was blocked, which lead to a situation that put the life of the patient in danger.I would like you to investigate the incident.Luckily, the patient did not suffer any harm, but i would like you to investigate this incident to avoid incidents like this in the future.It is the second time we experience this problem in his month.For the moment, all disinfection caps are blocked from use.Furthermore, my colleague and i noticed that the quality of the caps is bad.The alcohol pad is often out of place and no longer centrally located after use.The position of the pad cannot be corrected after attaching and detaching the cap several times.

• Brand Name: CAP DISINFECTION SINGLES CE
• Type of Device: CAP DISINFECTOR
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 9285898
• MDR Text Key: 165421354
• Report Number: 1911916-2019-01163
• Device Sequence Number: 1
• Product Code: LKB
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 306598
• Device Lot Number: 9039512
• Date Manufacturer Received: 10/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death