MAUDE Adverse Event Report: CAREFUSION, INC SAFE-T-CENTESIS KIT 6FR X 16CM- PIG1260K; THORACENTESIS TRAY

Model Number PIG1260K

Device Problem Unsealed Device Packaging (1444)

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

Event Date 06/14/2021

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(4) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4) see manufacture narration.

Event Description

Item received in last order and was not sealed correctly, therefore product was not sterile and could not be used.

Manufacturer Narrative

Pr (b)(4) follow-up emdr for device evaluation: three photos and one sample of lot 0001373678 was provided to our quality team for investigation.During visual inspection it was observed that the pouch is not sealed correctly.The seal in the pouch appears to be incomplete; therefore, the reported failure could be verified.A review of the internal manufacturing device records and raw material history files for reported lot 0001373678 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections throughout manufacturing, including verification that the package seal is complete and free from defects, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.A review of machine records verified that all machine parameters were within required limits, there was no evidence that any corrective maintenance was performed on the sealing machines.Based on the available information we are not able to identify a definitive root cause at this time.Complaints received for this device and defect will continue to be monitored for future occurrences.H3 other text : see manufacturer here.

Event Description

Item received in last order and was not sealed correctly, therefore product was not sterile and could not be used.

• Brand Name: SAFE-T-CENTESIS KIT 6FR X 16CM- PIG1260K
• Type of Device: THORACENTESIS TRAY
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• MDR Report Key: 12053529
• MDR Text Key: 267350901
• Report Number: 9680904-2021-00067
• Device Sequence Number: 1
• Product Code: PXI
• UDI-Device Identifier: 10885403076114
• UDI-Public: (01)10885403076114
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PIG1260K
• Device Catalogue Number: PIG1260K
• Device Lot Number: 0001373678
• Date Manufacturer Received: 08/16/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other