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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.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.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 ballooned during use.The following was received from the initial reporter: product quality issue with an infusion tubing set for the alaris lvp module.As shown in the picture below, there is a large expansion/swelling that has formed in the pump channel segment and this had occluded the line stopping the infusion.The exact lot and model number of this tubing set is unknown, this infusion was actively administering to a patient, but upon identification of the tubing issue subsequent to a line occlusion alarm, the tubing set was swapped for another set and infusion completed.No patient harm was identified.

Manufacturer Narrative

It was reported by customer that there is a large expansion/swelling that has formed in the pump channel segment and this had occluded the line stopping the infusion.One photo and one sample unknown infusion set was provided for quality investigation.The silicone tubing, below the upper pumping segment fitting, shows signs of being stretched beyond its intended limits, which are results of bulging or ballooning of the silicone tubing of the pumping segment.The customer complaint of bulge / balloon in the silicone segment was confirmed with the photo provided and visual inspection of the returned sample.The was no sign of additional damages to the infusion set.The probable root cause for the failure is determined to be a user issue.If the infusion set is not loaded correctly, a ballooning in the pumping segment tubing is possible.The clinical team has been made aware of the issue and the issue has been communicated with the customer with additional instructional material for proper loading of the alaris pumps.A device history record review could not be performed because the lot number is unknown.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.

Event Description

No additional information was provided.Mat#:unknown; lot#: unknown.It was reported by customer that there is a large expansion/swelling that has formed in the pump channel segment and this had occluded the line stopping the infusion.Verbatim: complaint received via email.Email(s) attached.Product quality issue with an infusion tubing set for the alaris lvp module.As shown in the picture below, there is a large expansion/swelling that has formed in the pump channel segment and this had occluded the line stopping the infusion.The exact lot and model number of this tubing set is unknown, although based on institutional standards i believe it to be 2204-0007 or 2426-0007.Only this one instance was identified or reported.This infusion was actively administering to a patient, but upon identification of the tubing issue subsequent to a line occlusion alarm, the tubing set was swapped for another set and infusion completed.No patient harm was identified.

• 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: 17861245
• MDR Text Key: 324804178
• Report Number: 2243072-2023-01771
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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: 01/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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