MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. UNSPECIFIED BD INTIMA II CATHETER; INTERVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 10/17/2019

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 unspecified bd intima ii catheter was involved in an allergic reaction during use.After the patient was discharged, they experienced an abscess left at the puncture site.The abscess was disinfected and cleaned, and clean dressings were applied.After an examination four days later, pus was still found resulting in the patient being admitted for "abscess incision." the following information was provided by the initial reporter: the patient was hospitalized on (b)(6) 2019.Due to neonatal hyperbilirubinemia, and he was discharged on october 16th for 4 days, during that time he was treated with blue light irradiation and indwelling needle infusion.On the second day after discharge, the parents carried the children to the ward, and the nurse found a small rice grain size abscess at the puncture site, and a centimeter of skin strip like redness along the direction of the blood vessels above the puncture site.The hydrocolloid dressing was applied for cleaning and disinfection, and the abscess at the puncture site was treated with dressing change with observing changes dynamically.Four days later, there was still pus, and the patient was admitted for abscess incision.

Manufacturer Narrative

Investigation summary unfortunately the provided lot number could not be validated in our database.Since a valid lot number could not be connected to the device identified in the complaint, bd investigators could not conduct a device history review for this event.Additionally, a sample has not yet been submitted for evaluation and testing, preventing bd engineers from conducting a full investigation and determining a root cause of the failure mode identified in the description of the event.Examination of the product involved may provide clarification as to the cause for the reported failure.

Event Description

It was reported that the unspecified bd intima ii catheter was involved in an allergic reaction during use.After the patient was discharged, they experienced an abscess left at the puncture site.The abscess was disinfected and cleaned, and clean dressings were applied.After an examination four days later, pus was still found resulting in the patient being admitted for "abscess incision." the following information was provided by the initial reporter: the patient was hospitalized on (b)(6) 2019.Due to neonatal hyperbilirubinemia, and he was discharged on october 16th for 4 days, during that time he was treated with blue light irradiation and indwelling needle infusion.On the second day after discharge, the parents carried the children to the ward, and the nurse found a small rice grain size abscess at the puncture site, and a centimeter of skin strip like redness along the direction of the blood vessels above the puncture site.The hydrocolloid dressing was applied for cleaning and disinfection, and the abscess at the puncture site was treated with dressing change with observing changes dynamically.Four days later, there was still pus, and the patient was admitted for abscess incision.

• Brand Name: UNSPECIFIED BD INTIMA II CATHETER
• 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: 9540116
• MDR Text Key: 182212704
• Report Number: 3006948883-2019-01157
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other