MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 22G X 1.00IN (0.9 X 25 MM) W/ Y INTIMA II; INTERVASCULAR CATHETER

Catalog Number 383407

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

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 01/08/2019

Event Type  Injury  

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.

Event Description

It was reported that the 22g x 1.00in (0.9 x 25 mm) w/ y intima ii caused an allergic reaction to the patient, requiring medical intervention.Incident occurred during use of the device.The following information was provided by the initial reporter: several hours after usage of the catheter, skin reactions including redness, itching noticed on the patient.Medical intervention has been taken on the patient.Reactions has been turned down.

Manufacturer Narrative

Investigation: a device history review was conducted for lot number 6294176.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that the 22g x 1.00in (0.9 x 25 mm) w/ y intima ii caused an allergic reaction to the patient, requiring medical intervention.Incident occurred during use of the device.The following information was provided by the initial reporter: several hours after usage of the catheter, skin reactions including redness, itching noticed on the patient medical intervention has been taken on the patient reactions has been turned down.

• Brand Name: 22G X 1.00IN (0.9 X 25 MM) W/ Y INTIMA II
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou
• MDR Report Key: 8776893
• MDR Text Key: 150596638
• Report Number: 3006948883-2019-00530
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K143610
• 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: 08/01/2019

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 Expiration Date: 11/30/2019
• Device Catalogue Number: 383407
• Device Lot Number: 6294176
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other