MAUDE Adverse Event Report: BECTON DICKINSON BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS; INTRAVASCULAR ADMINISTRATION SET

Catalog Number CS42522E-07

Device Problem Component Missing (2306)

Patient Problem Insufficient Information (4580)

Event Date 04/10/2023

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this bd device may have been manufactured.A 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.H3.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 the bd alaris medical infusion system administration sets roller clamp was not on tubing.The following was recieved by the initial reporter: verbatim: roller clamp was not on tubing.

Event Description

It was reported that the bd alaris medical infusion system administration sets roller clamp was not on tubing.The following was received by the initial reporter: verbatim: roller clamp was not on tubing.

Manufacturer Narrative

Investigation summary: a complaint of set missing roller clamp was received from the customer.A sample was returned for investigation.Through visual inspection, the customer complaint was confirmed.The roller clamp was missing from the set.A device history record review for model cs42522e-07 lot number 22119265 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The manufacturing plant was notified of this defect and an investigation was performed.After investigation, it was defined that the misassembly (missing roller clamp) can be related to assembler distraction, accumulation of material and opportunities in fixture.As containment action, a quality alert was created and communicated to production personnel to inform of this failure mode and reinforce the operation to avoid missing roller clamp in the assembly.

• Brand Name: BD ALARIS MEDICAL INFUSION SYSTEM ADMINISTRATION SETS
• 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: 17480887
• MDR Text Key: 320600410
• Report Number: 2243072-2023-01388
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• 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: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CS42522E-07
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• 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