MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. ANGIOCATH 22GA X 1,00IN 0,9 X 25MM; INTRAVASCULAR CATHETER

Catalog Number 38833514

Device Problem Packaging Problem (3007)

Patient Problems Hyperemia (1904); Phlebitis (2004)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: there was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.The manufacturing facility has been notified of this incident and the findings.A review of the device history record was performed and no quality issues were found during production.Investigation conclusion: not confirmed: bd was unable to confirm the complaint for the defects claimed.Root cause description: in addition to the lack of evidence that could cause this complaint during the analysis of the batch history, corrective maintenance and non-conformities, we did not receive photos and samples to carry out the analysis of the reported defect.Since an investigation could not be performed bd was unable to determine a possible root cause.Rationale: complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.

Event Description

It was reported that the angiocath 22ga x 1,00in 0,9 x 25mm sterility was compromised and the patient developed phlebitis and hyperemia as a result.The following information was provided by the initial reporter, translated from portuguese to english: "phlebitis caused by abocath, hyperemia.".

Event Description

It was reported that the angiocath 22ga x 1,00in 0,9 x 25mm sterility was compromised and the patient developed phlebitis and hyperemia as a result.The following information was provided by the initial reporter, translated from portuguese to english: "phlebitis caused by abocath, hyperemia.".

Manufacturer Narrative

Correction: after further evaluation of the complaint, it has been determined that the previously submitted report was sent in error.A minor, localized allergic reaction with no report of serious injury, medical intervention, or device malfunction is not considered to be a reportable malfunction.

• Brand Name: ANGIOCATH 22GA X 1,00IN 0,9 X 25MM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 11004049
• MDR Text Key: 221455362
• Report Number: 9610048-2020-00174
• 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
• Type of Report: Initial,Followup
• Report Date: 01/18/2021

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
• Device Catalogue Number: 38833514
• Device Lot Number: 9274982
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 01/18/2021
• Supplement Dates FDA Received: 01/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other