MAUDE Adverse Event Report: BECTON DICKINSON IV SET/60DROP/2CQ/F/SB/50CM; IV ADMINISTRATION SET

Catalog Number 385523-ZAT

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 03/10/2018

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.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.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 two iv set/60drop/2cq/f/sb/50cm experienced blood spatter.The following information was provided by the initial reporter: blood leaked from the filter.

Manufacturer Narrative

H.6.Investigation: the air tightness of the actual product (jis standard: 150 kpa for 15 minutes, no pressure leakage) was confirmed.As the offer, the liquid leaked from the filter part (lower part) it was recognized.Therefore, we asked the manufacturer of the filter to investigate the parts.According to the survey results by the filter manufacturer, according to the survey results, in all cases, liquid leakage was observed from the air vent (air hole) of the filter housing, and liquid permeation was observed in the hydrophobic filter inside the housing.It is assumed that the hydrophobic filter has become hydrophilic and a leak has occurred due to the following phenomena as described in the package insert, as no manufacturing abnormalities were observed.H3 other text : see h.10.

Event Description

It was reported that two iv set/60drop/2cq/f/sb/50cm experienced blood spatter.The following information was provided by the initial reporter: blood leaked from the filter.

• Brand Name: IV SET/60DROP/2CQ/F/SB/50CM
• Type of Device: IV ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8542050
• MDR Text Key: 145509395
• Report Number: 2243072-2019-00770
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 385523-ZAT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other