MAUDE Adverse Event Report: BECTON DICKINSON IV SET/N35/20DROP/CQX1/LL; IV ADMINISTRATION SET

Catalog Number 515541-ZAT

Device Problem Leak/Splash (1354)

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

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: when we checked the actual product, we found that the shape of the roller was abnormal, as requested.The roller part is a defective molding product that could not meet the intended shape because the mold was not filled with a sufficient amount of material at the time of manufacturing.It was presumed that there was an overlap in the inaccuracies that could not be detected in the 100% appearance inspection after assembly.A total of 277 stored specimens (products stored for each serial number) equipped with this part with the same serial number confirmed no abnormalities in the shape of this part.We re-educated the isolation of conditionally conditioned products at the start of molding and visual inspection.Oem manufacture: 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.

Event Description

It was reported that the iv set/n35/20drop/cqx1/ll experienced tubing loose/tubing clamp defective/deformed.Product defect was noted during use.The following information was provided by the initial reporter: used for granisetron.The shape of the roller clamp was differ from usual.Hcp had difficulty to control drip amount.

• Brand Name: IV SET/N35/20DROP/CQX1/LL
• Type of Device: IV 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9534250
• MDR Text Key: 178028520
• Report Number: 2243072-2019-02922
• Device Sequence Number: 1
• Product Code: FPA
• 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
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: 515541-ZAT
• Device Lot Number: 1907142C
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2019
• 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