MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) VENFLON PRO 20GA 1.1MM OD 32MM L INDIA; INTERVASCULAR CATHETER

Catalog Number 393234

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 07/20/2020

Event Type  Injury  

Manufacturer Narrative

Investigation summary: one photo was received by our quality team for evaluation.The returned photo shows the top web of the package.The team was unable to confirm the customer experience as no sample was returned.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The endotoxins test results for this batch have been reviewed and is within the acceptance criteria.Therefore, the root cause cannot be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Investigation conclusion: 1 photo was returned for investigation.The photo show the top web with batch #9201066.Unable to confirm the customer experience as no sample was returned.End user risk assessment as per p-eura document, eurap2053015, severity is limited (s2) occurrence = (sum of defective samples for all complaints / batch quantity) x 1,000,000 = ((b)(4)) x 1,000,000 = (b)(4) which is occasional (o3) the risk is acceptable per (b)(4).Root cause description: as no sample and no photo was returned, a review of past 12 months quality notification was performed.No similar quality notification was raised for the reported defect.The endotoxins test results for this batch has been reviewed and it is within the acceptance criteria.Therefore, the root cause cannot be determined.Complaint will be reopened when sample is returned.Rationale: the root cause cannot be determined.Complaint trend would be monitored.

Event Description

It was reported that 5 venflon pro 20ga 1.1mm od 32mm l india were involved with a patient experiencing a systemic infection in the form of a fever.It has not been specified what, if any, additional medical attention/care was received as a result of the fever.The following information was provided by the initial reporter: phlebitis and fever occurs, next day of insertion of cannula, their consumption is 100 units per month , main concern is fever.

Manufacturer Narrative

The following information has been corrected: date of event: (b)(6) 2020.

Event Description

It was reported that 5 venflon pro 20ga 1.1mm od 32mm l india were invovled with a patient experiencing a systemic infection in the form of a fever.It has not been specified what, if any, additional medical attention/care was received as a result of the fever.The following information was provided by the initial reporter: phlebitis and fever occurs , next day of insertion of cannula, their consumption is 100 units per month , main concern is fever.

• Brand Name: VENFLON PRO 20GA 1.1MM OD 32MM L INDIA
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10402229
• MDR Text Key: 204083048
• Report Number: 8041187-2020-00484
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 393234
• Device Lot Number: 9201066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other