MAUDE Adverse Event Report: BECTON DICKINSON BD¿ INFUSION SET R 87 G WITH PRECISION REGULATOR

Catalog Number 396392

Device Problem Gas/Air Leak (2946)

Patient Problem Pulmonary Embolism (1498)

Event Date 10/26/2018

Event Type  Injury  

Manufacturer Narrative

There are multiple bd locations where this unspecified 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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.(b)(6).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 with the use of the bd¿ infusion set r 87 g with precision regulator there was an issue with not airtight drop regulator.Therefore air could be sucked into the tubing so that through the port air could get into the vein.The customer has suffered a pulmonary embolism.There was no report of medical intervention.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 1008743.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally visual observation of the returned device allowed our engineers to determine that the root cause to be an irregularity in the molding process.11 samples received in unopened original packaging, after additional request pictures of the unit involved was provided.Investigation was carried out based on dhr review and user description of the event, pictures that were provided were visually inspected, drawing of air is clearly visible, the sample air intake starts on the flow regulation component.All tests have passed on this lot list and all testing can be seen.11 samples were tested and all samples passed functional and underwater leak test.Visual inspection was also conformal.Probable root cause is molding defect on the bottom part of the flow control component of the product caused air intake in the system.

Event Description

It was reported with the use of the bd¿ infusion set r 87 g with precision regulator there was an issue with not airtight drop regulator.Therefore air could be sucked into the tubing so that through the port air could get into the vein.The customer has suffered a pulmonary embolism.There was no report of medical intervention.

• Brand Name: BD¿ INFUSION SET R 87 G WITH PRECISION REGULATOR
• Type of Device: INFUSION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8085950
• MDR Text Key: 127616794
• Report Number: 2243072-2018-01630
• Device Sequence Number: 1
• Product Code: FPA
• 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: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 396392
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/02/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other