MAUDE Adverse Event Report: HAEMONETICS CORPORATION PCS2 PLASMA COLLECTION SYSTEM; NEEDLE, SYS 16G, JMS 822-1616

Model Number 03018-01

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

Haemonetics confirmed reported malfunction via sample photos provided by customer.Sample was received by haemonetics but evaluation has yet to be completed.Without completed evaluation root cause has yet to be determined.

Event Description

On (b)(6) 2020 haemonetics was notified of metal particles at the tip of the cannula, utilizing the pcs®2 plasma collection system needle in (b)(6).This was discovered immediately after opening, the cannula was not inserted.There was no patient involved.

• Brand Name: PCS2 PLASMA COLLECTION SYSTEM
• Type of Device: NEEDLE, SYS 16G, JMS 822-1616
• Manufacturer (Section D): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer (Section G): HAEMONETICS CORPORATION; 125 summer street; boston MA 02110
• Manufacturer Contact: janice kiser ; 125 summer street; boston, MA 02110
• MDR Report Key: 11195059
• MDR Text Key: 228435393
• Report Number: 1219343-2020-00153
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 03018-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1