MAUDE Adverse Event Report: BECTON DICKINSON IV SET/C35/20DROP/1CQ1BAR/F/STD/50CM; INTRAVASCULAR CATHETER

Catalog Number 515565-ZAT

Device Problem Leak/Splash (1354)

Patient Problem Underdose (2542)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

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.Device expiration date: unknown.Device manufacture date: unknown.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 leakage occurred during use with a iv set/c35/20drop/1cq1bar/f/std/50cm.The following information was provided by the initial reporter, "when giving avastin, drug leaked from the filter.".

Event Description

It was reported that leakage occurred during use with a iv set/c35/20drop/1cq1bar/f/std/50cm.The following information was provided by the initial reporter, "when giving avastin, drug leaked from the filter.".

Manufacturer Narrative

Investigation summary when the airtightness of the actual product was checked (the relevant jis standard: 150kpa for 15 minutes, there was no water leakage when pressurized), liquid leakage was observed from the filter part (lower part).Therefore, we asked the filter manufacturer and distributor to investigate the material.According to the results of a survey by the filter manufacturer, the leak was caused by a crack in the upper vent membrane of the filter.The hydrophilic film on the side was also broken.Upon review of all production records, no nonconformance records were found.Based on the damaged state of the actual membrane, it was presumed that excessive back pressure was applied from the lower part of the filter, resulting in damage to the membrane and leakage.When injecting from the lower side of the filter, the user must be sure to close the clamp at the bottom of the filter so that there is no back pressure that may cause the filter to peel off.If any abnormality such as liquid leakage is detected, the user should stop using the product and replace it with a new product.No anomaly found on dhr.

• Brand Name: IV SET/C35/20DROP/1CQ1BAR/F/STD/50CM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9554691
• MDR Text Key: 178348238
• Report Number: 2243072-2019-02967
• Device Sequence Number: 1
• Product Code: FOZ
• 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: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515565-ZAT
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other