MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB; SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE

Catalog Number	303191
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2024
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.
Event or Problem Description
Description details: entire sponge (foam) dislodges during scrubbing.Foam fell out after scrubbing was an adverse event associated with device deficiency? no.
Additional Manufacturer Narrative
(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 303191 and lot number 4229948.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
No additional information received.

• Brand Name: SYRINGE 10ML SALINE POSIFLUSH SAFESCRUB
• Common Device Name: SALINE VASCULAR ACCESS FLUSH WITH INTEGRATED ALCOHOL DISINFECTANT DEVICE
• 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: 21019276
• Report Number: 1911916-2024-00948
• Device Sequence Number: 9133663
• Product Code: QTI
• UDI-Device Identifier: 50382903031912
• UDI-Public: (01)50382903031912(11)240816(17)270731(10)4229948
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K213955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2025

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: 303191
• Device Lot Number: 4229948
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Supplement Date Received by Manufacturer: 01/22/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Sex: Female