MAUDE Adverse Event Report: BECTON DICKINSON BD CATHENA 22GX1.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386806
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no physical sample, lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.Based on the limited investigation results, a root cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd cathena 22gx1.00in straight bc leaked.It was reported by the customer that patient piv to r acf noted to be leaking by nurse, same was flushed and continued to leak, iv removed as same was leaking.Discovered a wound at the insertion site of the iv, as well as two pressure wounds above and lateral to insertion side, and below and medial.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4).Date of incident (yyyy-mm-dd): 2024-01-09 site name/location: xxxx level of harm: minimal harm ahs optional report to cmdsnet (health canada): yes incident details: patient piv to r acf noted to be leaking by nurse, same was flushed and continued to leak, iv removed as same was leaking.Discovered a wound at the insertion site of the iv, as well as two pressure wounds above and lateral to insertion side, and below and medial.Impact of incident: pain, discomfort.Iv was removed, catheter intact, pt skin cleaned with normal saline and covered with a 2x2 gauze and tape.Who was affected? patient device information device name/description: catheter iv safety non-winged with multiguard 22gax1.00in cathena manufacturer: xxxxxx serial or lot number: unknown device expiry date (yyyy-mm-dd): unknown supplier: xxxxx supplier catalogue number: xxxx was the device retained? no.

• Brand Name: BD CATHENA 22GX1.00IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19666992
• Report Number: 2243072-2024-00779
• Device Sequence Number: 17798163
• Product Code: FOZ
• UDI-Device Identifier: 00382903868063
• UDI-Public: (01)00382903868063
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: UNK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 386806
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown