MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ EXTENSION SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number UNKNOWN

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 09/13/2023

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and/or 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 franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.The reported lot number [15188924] was reported, however, this lot # could not be located in sap.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.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 the unspecified bd¿ extension set tubing balloned.Report 1 of 2.The following was received from the initial repoter: event description: patient was in critical condition in an out of v-fib requiring cpr and cardiac shock.Iv in l ac.Medication (amiodarone) was infusing for approx.60 min without difficulty.The iv was checked several times and the iv flushed without difficulty.Other medications were infusing through the same iv without difficulty.The pump kept alarming iv occluded pt side.The pump looked like it was being pried open from the top.The door was not like this prior.The door was opened and the tubing was found with a large balloon of fluid aprox 10cc at the connection between the white line and the blue connector over the air sensor.When the tubing was removed the connector fell apart into 3 pieces.

Event Description

New information: the approximate time that medication was not infusing was 20-40 minutes.The patient went into an arrhythmia and then cardiac arrest in which the medication was given via ivp.The patient then went to the cath lab.It was reported the unspecified bd¿ extension set tubing ballooned.Report 1 of 2.The following was received from the initial reporter: event description: patient was in critical condition in an out of v-fib requiring cpr and cardiac shock.Iv in l ac.Medication (amiodarone) was infusing for approx.60 min without difficulty.The iv was checked several times and the iv flushed without difficulty.Other medications were infusing through the same iv without difficulty.The pump kept alarming iv occluded pt side.The pump looked like it was being pried open from the top.The door was not like this prior.The door was opened and the tubing was found with a large balloon of fluid aprox 10cc at the connection between the white line and the blue connector over the air sensor.When the tubing was removed the connector fell apart into 3 pieces.

Manufacturer Narrative

No additional information no product or photo was returned by the customer.The customer complaint that there was a bulge in the silicone segment could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a model and lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.

• Brand Name: UNSPECIFIED BD¿ EXTENSION SET
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: jennifer suh ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17840459
• MDR Text Key: 324571097
• Report Number: 2243072-2023-01746
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• 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