MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ N IV CATHETER; INTRAVENOUS CATHETER

Catalog Number 388411

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: (b)(4) photos were returned for investigation.Fm was observed in the returned photos.One actual sample without packaging was returned for investigation.Figure 1: actual sample.The actual sample was subjected to visual inspection.Fm was observed on the catheter of the returned sample.Cellulose is commonly used in paper and fabric industry.Figure 2: fm on catheter.The fm was subjected to fourier transform infrared spectroscopy test.The ftir results showed that the spectrum of the fm matched the spectrum of cellulose.Investigation conclusion: fm was observed on the catheter of the returned sample.Root cause description: fm was observed on the catheter of the returned sample.Upon further investigation, the white particle and fiber fm could have been transferred from the manufacturing environment during handling or the assembly process.Job aid for housekeeping standard in insyte assembly and packaging process had been established.A communication will be conducted to all manufacturing associates to raise awareness on the nonconformance, proper gmp and housekeeping procedures.The trend of the nonconformance will be continually monitored.

Event Description

It was reported that the hcp observed the with bd insyte¿ n iv catheter blood control technology was rough and uneven prior to use.No serious injury or medical intervention noted.

• Brand Name: BD INSYTE¿ N IV CATHETER
• Type of Device: INTRAVENOUS CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7101590
• MDR Text Key: 94849591
• Report Number: 8041187-2017-00265
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K942045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/08/2017

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 Health Care Professional
• Device Catalogue Number: 388411
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2017
• Initial Date FDA Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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