MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. MINILOC SAFETY INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number ASFSF004

Device Problems Product Quality Problem (1506); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/23/2022

Event Type  malfunction  

Event Description

After accessing patient's implanted port using minilock 22g 3/4in needle, i drew labs per protocol.While cleaning end of line with alcohol swab, the swab got caught on something sharp.I noticed a shard of plastic was hanging off the end of the line.It was still attached to product and did not dislodge.Pt did not experience any harm from defected product.I deaccessed pt's port and threw product away but kept original packaging.Fda safety report id# (b)(4).

• Brand Name: MINILOC SAFETY INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; salt lake city UT 84116
• MDR Report Key: 15300983
• MDR Text Key: 298874793
• Report Number: MW5111728
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2024
• Device Lot Number: ASFSF004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/25/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANTED PORT
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 70 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White