MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN; INTRAVASCULAR CATHETER

Catalog Number	383336
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd saf-t-intima w/y adapter pnk 20gax1.0in cap loose.It was reported by customer that pt with pink butterfly iv, called reporting "bleeding" rn went to assess pt, found that clear cap had fallen off of piv and blood leaking out of iv.Blue luer lock was placed instead of clear cap.Verbatim#: rcc received a complaint via email.Bd item # 383336 (saf-t-intima integrated catheter system with y adapter, pink, 20g x 1").The event occurred on (b)(6)2024.Issue - leaking.Pt with pink butterfly iv, called reporting "bleeding" rn went to assess pt, found that clear cap had fallen off of piv and blood leaking out of iv.Blue luer lock was placed instead of clear cap.1.The event occurred on (b)(6)2024.2.I do not have a lot number, as the packaging was not saved.3.The defective item was not saved and cannot be sent for further assessment.4.There was no harm to patient or staff.5.To my knowledge, this issue has only happened once.
Additional Manufacturer Narrative
Investigation results: as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of product malfunction during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.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
No additional information.

• Brand Name: BD SAF-T-INTIMA W/Y ADAPTER PNK 20GAX1.0IN
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21069445
• Report Number: 9610847-2024-00403
• Device Sequence Number: 8409075
• Product Code: FOZ
• UDI-Device Identifier: 00382903833368
• UDI-Public: (01)00382903833368
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K013800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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: 383336
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown