MAUDE Adverse Event Report: BECTON DICKINSON PRM/N35/STD/50CM; INFUSION SET CONNECTOR

Catalog Number 515573

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/19/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the prm/n35/std/50cm experienced flow issues when used for infusion during use.The following information was provided by the initial reporter: the main line was an infusion set.Connected 515573-zat as a side tube.Connected 515573-zat to the main line and flowed antiemetics and chemo in the main line.Connected chemo medication with spike needle to 515573-zat but the chemo didn't flow even pressed the infusion bag.Replaced by new 515573-zat and it started to flow.

Event Description

It was reported that the prm/n35/std/50cm experienced flow issues when used for infusion during use.The following information was provided by the initial reporter: the main line was an infusion set.Connected 515573-zat as a side tube.¿ connected 515573-zat to the main line and flowed antiemetics and chemo in the main line.¿ connected chemo medication with spike needle to 515573-zat but the chemo didn't flow even pressed the infusion bag.Replaced by new 515573-zat and it started to flow.

Manufacturer Narrative

H.6.Investigation summary: connected the injector part of the actual product (515573-zat, which was discontinued due to clogging) to the spike set (faceal connector luer lock), and confirmed that the liquid flowed.In addition, when the lure connector of the actual product (515573-zat that was blocked and was discontinued) was connected to the mixed injection part upstream of the drip tube of the chemosafe infusion set, liquid flowed out of the end of the chemo safe infusion set without any problems.The cause could not be identified because there was no abnormality such as clogging, and the event was not reproduced.This event is presumed to have occurred due to incomplete connection.In order to prevent the occurrence of poor fluid flow, as part of continuous quality improvement, we changed the shape of the terminal luer connector to the luer lock integrated type (fixed lock) so that the connection can be made more reliably.A review of the device history record revealed no irregularities during the manufacture of the reported lot.H3 other text : see section h.10.

• Brand Name: PRM/N35/STD/50CM
• Type of Device: INFUSION SET CONNECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8764732
• MDR Text Key: 150704241
• Report Number: 2243072-2019-01335
• Device Sequence Number: 1
• Product Code: LHI
• 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: 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: 515573
• Device Lot Number: 1902032C
• Date Manufacturer Received: 06/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other