MAUDE Adverse Event Report: BECTON DICKINSON CAP DISINFECTION SINGLES CE; CAP, DEVICE DISINFECTANT

Catalog Number	PMCF BD PUREHUB
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
External ref # (b)(4).Material no: unknown batch no: unknown.It was reported that clinician encountered cracking while using bd purehub¿ disinfecting cap single (sku 306598) to disinfect needle-free luer connectors prior to i.V.Access and to act as a physical barrier between line accesses.Clinician experienced: tiende a partirse cuando se da varias vueltas al producto o se ha utlizado durante más de un turno - tends to crack when the product is turned several times or has been used for more than one shift.-tapón roto con una grieta - broken cap with a split.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4) follow up: as no physical sample, valid part number or 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.

• Brand Name: CAP DISINFECTION SINGLES CE
• Common Device Name: CAP, DEVICE DISINFECTANT
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 21360733
• Report Number: 1911916-2025-00094
• Device Sequence Number: 8452849
• Product Code: QBP
• UDI-Device Identifier: 00382903065967
• UDI-Public: (01)00382903065967
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K193190
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: PMCF BD PUREHUB
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/17/2025
• 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