MAUDE Adverse Event Report: BECTON DICKINSON PRM/N35/STD/50CM; EXTENSION TUBING

Catalog Number 515573-ZAT

Device Problem Complete Blockage (1094)

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

Event Date 07/17/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the injector part of the actual product that was received was connected to a spike set, and when the liquid flow was confirmed, the liquid flowed out without any problems.In addition, when the actual luer lock connector part was connected to the mixed injection part upstream of the drip tube of the chemosafe infusion set, the liquid flowed without 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.No anomaly was found on the dhr review.

Event Description

It was reported that the prm/n35/std/50cm was connected to the terumo infusion set, but saline wouldn't flow through it during use.The following information was provided by the initial reporter, translated from japanese to english: "connected to terumo infusion set.However saline didn't flow.Replaced by new product and it flowed.".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.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.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 prm/n35/std/50cm was connected to the terumo infusion set, but saline wouldn't flow through it during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "connected to terumo infusion set.However saline didn't flow.Replaced by new product and it flowed.".

• Brand Name: PRM/N35/STD/50CM
• Type of Device: EXTENSION TUBING
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9005911
• MDR Text Key: 168703869
• Report Number: 2243072-2019-01996
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 515573-ZAT
• Device Lot Number: 1811212C
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2019
• Initial Date FDA Received: 09/12/2019
• Supplement Dates Manufacturer Received: 08/28/2019
• Supplement Dates FDA Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2019
• 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
• Patient Outcome(s): Other