MAUDE Adverse Event Report: CAREFUSION, INC SHUNT PAK, 11.5FR DOUBLE-VALVE

Catalog Number 42-2090

Device Problem Contamination (1120)

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

Event Date 06/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

The customer reported that there is something like a large piece of vinyl between the outer tray and inner tray.Verbatim: there is something like a large piece of vinyl between the outer tray and inner tray.Incoming inspection discovered this contamination before being used for patients.

Event Description

The customer reported that there is something like a large piece of vinyl between the outer tray and inner tray.Verbatim: there is something like a large piece of vinyl between the outer tray and inner tray.Incoming inspection discovered this contamination before being used for patients.

Manufacturer Narrative

(b)(4).Follow-up emdr for device evaluation: one photo and two samples were provided to our quality team for investigation.Through visual inspection, piece of plastic was in the empty pack observed.The plastic did not resemble any product components therefore, the reported failure mode was confirmed.A review of the internal manufacturing device records and raw material history files for the reported lot number 0001458149 was performed and no recorded quality problems or rejections related to this incident were found.Product undergoes inspections during manufacturing, no issues related to the reported incident were identified, all procedural and functional requirements for product release have been met.Based on the available information a probable root cause was manufacturing related.Awareness training was conducted.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text: see manufacture narration.

• Brand Name: SHUNT PAK, 11.5FR DOUBLE-VALVE
• Type of Device: NA
• Manufacturer (Section D): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer (Section G): CAREFUSION, INC; 400 east foster rd; mannford OK 74044
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 14775278
• MDR Text Key: 303159309
• Report Number: 1625685-2022-00066
• Device Sequence Number: 1
• Product Code: KPM
• UDI-Device Identifier: 50885403421370
• UDI-Public: (01)50885403421370
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42-2090
• Device Lot Number: 0001458149
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other